MACULAR DEGENERATION AND OCULAR TUMOR TREATMENT

Transcription

MACULAR DEGENERATION AND OCULAR
TUMOR TREATMENT
Protocol: OPT015
Effective Date: August 12, 2013
Table of Contents
Page
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE......................................... 1
BACKGROUND ...................................................................................................................................... 3
CLINICAL EVIDENCE ........................................................................................................................... 4
U.S. FOOD AND DRUG ADMINISTRATION (FDA) ........................................................................ 15
APPLICABLE CODES .......................................................................................................................... 17
REFERENCES ....................................................................................................................................... 17
PROTOCOL HISTORY/REVISION INFORMATION ........................................................................ 22
INSTRUCTIONS FOR USE
This protocol provides assistance in interpreting UnitedHealthcare benefit plans. When deciding
coverage, the enrollee specific document must be referenced. The terms of an enrollee's document
(e.g., Certificate of Coverage (COC) or Evidence of Coverage (EOC)) may differ greatly. In the event
of a conflict, the enrollee's specific benefit document supersedes this protocol. All reviewers must first
identify enrollee eligibility, any federal or state regulatory requirements and the plan benefit coverage
prior to use of this protocol. Other Protocols, Policies and Coverage Determination Guidelines may
apply. UnitedHealthcare reserves the right, in its sole discretion, to modify its Protocols, Policies and
Guidelines as necessary. This protocol is provided for informational purposes. It does not constitute
medical advice.
UnitedHealthcare may also use tools developed by third parties, such as the MCG™ Care Guidelines,
to assist us in administering health benefits. The MCG™ Care Guidelines are intended to be used in
connection with the independent professional medical judgment of a qualified health care provider and
do not constitute the practice of medicine or medical advice.
COMMERCIAL, MEDICARE & MEDICAID COVERAGE RATIONALE
Implantable Miniature Telescope (IMT)
The implantable miniature telescope is medically necessary when used according to U.S. Food and
Drug Administration (FDA) labeled indications for the treatment of patients with end-stage, agerelated macular degeneration. See the FDA section of this policy for a complete list of FDA indications
and contraindications for IMT.
Transpupillary Thermotherapy (TTT)
Transpupillary thermotherapy is medically necessary for the treatment of retinoblastoma and
choroidal melanoma.
Macular Degeneration & Ocular Tumor Treatment
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Transpupillary thermotherapy is not medically necessary for the treatment of choroidal
neovascularization or macular degeneration. Results of studies evaluating the use of transpupillary
thermotherapy for the prevention or control of choroidal neovascularization lesions in patients with
age-related macular degeneration (AMD) do not provide sufficient evidence to conclude that
transpupillary thermotherapy improves loss of vision due to AMD.
Conjunctival Incision with Placement of a Pharmacologic Agent
Conjunctival incision with posterior extrascleral placement of a pharmacologic agent has is not
medically necessary to treat ocular disorders including age-related macular degeneration.
Conjunctival incision with posterior extrascleral placement of a pharmacologic agent has not been
demonstrated to be as effective as standard therapy for ocular disorders including macular
degeneration. Further studies with larger sample sizes are needed to demonstrate the efficacy of this
treatment.
Epiretinal Radiation Therapy
Epiretinal radiation therapy is not medically necessary for the treatment of ocular disorders including
age-related macular degeneration.The evidence does not support the use of epiretinal radiation therapy.
Controlled trials with larger patient populations are needed to demonstrate the effectiveness of this
procedure.
Laser Photocoagulation
Laser photocoagulation is not medically necessary for the treatment of macular drusen. Results of
available studies lead to the conclusion that current prophylactic laser treatment does not benefit
patients who have macular drusen.
Medicare does not have a National Coverage Determination or a Local Coverage Determination for
Nevada for Transpupillary Thermotherapy, Photocoagulation Laser, and Conjunctival Incision with
Placement of a Pharmacologic Agent or Epiretinal Radiation Therapy and Panretinal (Scatter) Laser
Photocoagulation. Accessed June 2013. Medicare does have a National Coverage Determination for
Lasers (NCD 140.5), accessed June 2013 and it is as follows:
Medicare recognizes the use of lasers for many medical indications. Procedures performed with lasers
are sometimes used in place of more conventional techniques. In the absence of a specific non
coverage instruction, and where a laser has been approved for marketing by the Food and Drug
Administration, contractor discretion may be used to determine whether a procedure performed with a
laser is reasonable and necessary and, therefore, covered.
The determination of coverage for a procedure performed using a laser is made on the basis that the
use of lasers to alter, revise, or destroy tissue is a surgical procedure. Therefore, coverage of laser
procedures is restricted to practitioners with training in the surgical management of the disease or
condition being treated
For Medicare and Medicaid Determinations Related to States Outside of Nevada:
Please review Local Coverage Determinations that apply to other states outside of Nevada.
http://www.cms.hhs.gov/mcd/search
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Important Note: Please also review local carrier web sites in addition to the Medicare Coverage
database on the Centers for Medicare and Medicaid Services’ Website.
BACKGROUND
Age-related macular degeneration (AMD) is caused by deterioration of retinal photoreceptors in the
central portion of the retina. As AMD progresses, it develops into a "dry" form or a "wet" form. Wet
AMD is characterized by the growth of new blood vessels across the posterior of the eye, a process
known as choroidal neovascularization (CNV). These blood vessels are fragile and often leak blood
and serum, damaging the macular area of the retina and interfering with central vision.
The Implantable Miniature Telescope (IMT) (VisionCare Ophthalmic Technologies, Inc.) is a device
used for patients who are age 75 years or older who suffer from end-stage AMD. During the short
outpatient procedure, a surgeon inserts the device into the posterior chamber of only one eye. Although
the device eliminates peripheral vision in the affected eye, the untreated eye allows for peripheral
vision. Due to the risk of corneal endothelial cell loss which may lead to the need or corneal transplant,
the patient must meet specific criteria, including adequate peripheral vision before surgery and
willingness to enroll in a visual training or rehabilitation program. The IMT is the only telescope
system that is FDA approved for treatment of macular degeneration.
Transpupillary thermotherapy (TTT) of CNV lesions due to age-related macular degeneration involves
prolonged application of low-energy, infrared laser to areas of neovascularization thereby causing
photocoagulation. The goal of TTT is to stop the growth and leakage of the new blood vessels, thereby
preserving vision. Transpupillary thermotherapy has also been proposed to treat ocular tumors, such as
choroidal melanoma and retinoblastoma. The goal of TTT is to ablate cancerous masses by heating
them to temperatures as high as 60 degrees C. Healthy ocular tissue may also be damaged, but
generally the damage is limited to the site of treatment.
Conjunctival incision with posterior juxtascleral placement of a pharmacologic agent has been
proposed to treat age-related macular degeneration. During this procedure a small incision into the
superior temporal quadrant of the orbit is made posterior to the limbus between the superior and lateral
rectus muscle insertions. Gentle pressure is applied around the inserted cannula during administration
of the pharmacologic agent and removal of the cannula to prevent reflux and a semipressure patch is
applied. Advantages to the posterior juxtascleral placement of a pharmacologic agent include reduced
risk for retinal detachment and other safety issues associated with repeated intravitreal injections (a
common route of administration for pharmaceutical agents in the treatment of ocular disorders).
The Epi-Rad90 Ophthalmic SystemTM (NeoVista, Inc.) is an epiretinal radiation delivery device
developed to treat wet age-related macular degeneration. The Epi-Rad90 Ophthalmic System delivers
radiation (strontium 90) directly to the neovascular lesion in a single treatment therapy session. The
NeoVista device has not been approved for use in the United States; however, it is undergoing clinical
trials.
The Epi-Rad90 Ophthalmic SystemTM (NeoVista, Inc.) is an epiretinal radiation delivery device
developed to treat wet age-related macular degeneration. The Epi-Rad90 Ophthalmic System delivers
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radiation (strontium 90) directly to the neovascular lesion in a single treatment therapy session. The
NeoVista device has not been approved for use in the United States; however, it is undergoing clinical
trials.
A common early sign of dry AMD is macular drusen, yellow deposits under the retina. Although
drusen do not usually cause vision loss directly, the presence of many or large drusen is associated
with elevated risk of progression to advanced dry or wet AMD. Based on this association, many
investigators believed that destroying drusen with low-intensity laser light, a treatment known as
photocoagulation, would slow the development of AMD and/or prevent the progression from dry
AMD to wet AMD. If successful, laser photocoagulation of drusen could reduce loss of vision.
CLINICAL EVIDENCE
Implantable Miniature Telescope
In a prospective open-label clinical trial, called the IMT-002 clinical trial, Hudson et al. (2006)
evaluated the safety and efficacy of an implantable visual prosthetic device (IMT; VisionCare
Ophthalmic Technologies) in patients with bilateral, end-stage age-related macular degeneration
(AMD). A total of 217 patients (mean age, 76 years) with AMD and moderate to profound bilateral
central visual acuity loss (20/80 - 20/800) resulting from bilateral untreatable geographic atrophy,
disciform scars, or both were implanted with the IMT device. Fellow eyes were not implanted to
provide peripheral vision and served as controls. At 1 year, 67% of implanted eyes achieved a 3- line
or more improvement in best-corrected distance visual acuity (BCDVA) versus 13% of fellow eye
controls. Fifty-three percent of implanted eyes achieved a 3-line or more improvement in both
BCDVA and best-corrected near visual acuity (BCNVA) versus 10% of fellow eyes. Eleven eyes did
not receive the device because of an aborted procedure. Endothelial cell density (ECD) was reduced by
20% at 3 months and 25% at 1 year. The decrease in ECD was correlated with postsurgical edema, and
there was no evidence that endothelial cell loss is accelerated by ongoing endothelial trauma after
implantation. The authors concluded that the IMT visual prosthesis can improve visual acuity and
quality of life in patients with moderate to profound visual impairment caused by bilateral, end-stage
AMD.
At two years, data from the IMT-002 clinical trial that included 174 available patients were analyzed.
Overall, 103 (59.5%) of 173 telescope-implanted eyes gained three lines or more of BCVA compared
with 18 (10.3%) of 174 fellow control eyes. One telescope-implanted eye lost 3 lines of BCVA
compared with 13 in the control group. Mean endothelial cell density (ECD) stabilized through two
years, with 2.4% mean cell loss occurring from one to two years. There was no significant change in
coefficient of variation or percentage of hexagonal endothelial cells from within six months to two
years after surgery. The most common complication was inflammatory deposits. The authors
concluded that long-term results of the IMT prosthesis show the substantial BCVA improvement at
one year is maintained at two years. Key indicators of corneal health demonstrate ECD change that
reflects remodeling of the endothelium associated with the implantation procedure. The authors state
that ECD stabilizes over time, and there is no evidence of any ongoing endothelial trauma (Hudson et
al. 2008).
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The 2008 National Institute for Health and Clinical Excellence (NICE) guidance on implantable
miniature lens systems for the treatment of AMD states that the evidence on the efficacy of
implantation of miniature lens systems for advanced age-related macular degeneration shows that the
procedure can improve both vision and quality of life in the short-term. Short-term safety data are
available for limited numbers of patients. There is currently insufficient long-term evidence on both
efficacy and safety. Therefore this procedure should only be used with special arrangements for
clinical governance, consent and audit or research (NICE 2008).
Transpupillary Thermotherapy for Choroidal Neovascularization (CNV) Associated With AgeRelated Macular Degeneration (AMD):
In a 24-month, double-masked, randomized, active-controlled clinical trial, Söderberg et al. (2012)
compared the effect of combined low-dose transpupillary thermotherapy (TTT) and intravitreal
ranibizumab with sham TTT and intravitreal ranibizumab in patients with neovascular age-related
macular degeneration (AMD). A total of 100 patients were randomly assigned (1:1) to receive
intravitreal ranibizumab and sham TTT or intravitreal ranibizumab and low-dose TTT. Patients in the
TTT group required fewer treatments with ranibizumab compared to those in the sham TTT group. The
mean number of ranibizumab injections was 8.0 in the sham TTT group versus 6.3 in the TTT group
over two years. There was no statistically significant difference in best corrected visual acuity
(BCVA), central retinal thickness (CRT) or lesion area between the treatment groups at the final
examination. The results of the intent-to-treat population (92 patients) were similar to the per-protocol
(PP) population. The authors concluded that treatment with low-dose TTT significantly reduced the
number or intravitreal injections of ranibizumab over 24 months. According to the authors, these
results suggest that low-dose TTT can serve as an adjuvant in combination with intravitreal
ranibizumab for neovascular AMD. Further research with a larger number of patients is needed to
confirm these results.
Evidence from a large, multicenter, randomized controlled trial by Olk et al. (1999) suggests that
transpupillary thermotherapy can reduce drusen levels and improve visual acuity in patients with AMD
but does not decrease the incidence of CNV. Results also suggest that fewer complications occur when
TTT is given at a low intensity that does not cause visible burns for the treatment of drusen than when
used for photocoagulation of CNVs. However, this study has several methodological flaws, including a
follow-up period that may not be sufficient to fully evaluate the effects of transpupillary
thermotherapy. Standard periods of follow-up provided by studies of visible light laser
photocoagulation therapy have been 3 to 5 years, which suggests that similar follow-up should be
performed in studies of transpupillary thermotherapy for drusen. Other shortcomings of the trial by Olk
et al. include lack of blinding of patients and examiners to the treatment given and the fact that the
infrared laser manufacturer provided funding for this trial.
Odergren et al. (2008) compared the efficacy of low-dose transpupillary thermotherapy (TTT) and
verteporfin photodynamic therapy (PDT) in patients with occult neovascular age-related macular
degeneration (AMD). Patients were randomized to receive either low-dose TTT (136 mW/mm) (and
sham PDT) (n = 52) or PDT (and sham TTT) (n = 46) with retreatment if leakage was documented by
fluorescein angiography. The percent of patients losing fewer than 15 letters at 12 months was 75.0%
in the TTT group and 73.9% in the PDT group. The percent of patients with preserved or improved
best corrected visual acuity (BCVA) was 36.5% in the TTT group versus 23.9% in the PDT group. The
mean decrease in foveal thickness was 15% for TTT and 24% for PDT-treated patients, and the mean
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increase in total lesion area was -0.7% and -1.1%, respectively. The investigators concluded that lowdose TTT and PDT appeared to be equally efficient at stabilizing visual acuity in patients with occult
neovascular AMD. In the same group of patients, Odergren et al. (2010) compared the effects of lowdose transpupillary thermotherapy (TTT) and verteporfin photodynamic therapy (PDT) on patientreported visual function using the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ25) in patients with occult neovascular age-related macular degeneration (AMD). Patients were
followed for 12 months with retreatment according to clinical assessment. The NEI VFQ-25
questionnaire was administered at baseline and at 12 months. Forty-two patients (80.1%) in the TTT
group and 37 patients (80.0%) in the PDT group completed the questionnaire at the 12-month followup. The mean change in the NEI VFQ-25 composite score was +1.2 for the TTT group and +0.7 for
PDT group. None of the subscale categories showed significant changes between treatment groups at
12 months. Subgroup analysis showed that NEI VFQ-25 scores were lower in patients treated in their
better-seeing eye. The investigators concluded that in this randomized study on patients with occult
neovascular AMD, low-dose TTT and PDT appeared to be equally effective at stabilizing patientreported visual function. However, the study was not powered for this measure. Also, ranibizumab is
superior to PDT and low-dose TTT for all types of neovascular AMD.
Gustavsson and Agardh (2005) conducted a prospective, randomized, controlled pilot study of 28
patients with occult or minimally classic neovascularization. Nineteen patients were treated with TTT
and nine received sham treatment. A total of 21 patients were available to one year follow-up, 13 in the
TTT group and 8 in the sham group. Membrane diameter increased by a median of 350 microm in the
TTT group and 800 microm in the sham group and there was a loss in VA of more than or equal to 15
letters in 5/13 (38%) of the TTT group and 2/8 (25%) of the sham group.
Six case studies with a total n=286 and follow-up ranging from 6 to 24 months reported improvement
in visual acuity (VA) in 18%, stabilized VA in 51% and deteriorated VA in 35% of treated eyes (7,912). The two studies with 12-month or longer follow-up reported the VA had improved in 14%,
stabilized in 42% and deteriorated in 44% of treated eyes. (Algvere et al. 2001; Algvere et al. 2003;
Lin et al. 2002; Thach et al. 2004; Tranos et al. 2004; Verma et al. 2004)
In a prospective, interventional, comparative case series, Nowak et al. (2012) compared the efficacy of
verteporfin photodynamic therapy (PDT), intravitreal injections of bevacizumab (IVB), and
transpupillary thermotherapy (TTT) in patients with neovascular age-related macular degeneration
(AMD). The study included 426 eyes of 426 consecutive patients presenting with neovascular AMD.
Patients presented with subfoveal CNV predominantly classic, minimally classic, and occult with no
classic component; lesion size less than 5000 μm in the greatest linear dimension, and the area of
hemorrhages ≤1/3 were randomized to receive either PDT (group I) or IVB (group II) in a 1:1 ratio.
Other patients with CNV were included into the group III and received TTT. One hundred eyes were
treated with PDT. Mean baseline logMAR BCVA was 0.62 and final visual acuity decreased to 0.74;
104 eyes were treated with IVB. Mean baseline BCVA was 0.82and final visual acuity increased to
0.79; 222 patients were treated with TTT. Mean baseline BCVA was 1.10 and final visual acuity
decreased to 1.15. Among all eyes the average number of treatment sessions was 2.34. The authors
concluded that IVB injections had the best efficacy in the improvement of final BCVA. However, both
IVB and TTT demonstrated good stabilization of vision. The lack of a control group limits the validity
of the results of this study.
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Mitamura et al. (2009) compared the therapeutic efficacy of photodynamic therapy (PDT) to that of
transpupillary thermotherapy (TTT) for polypoidal choroidal vasculopathy (PCV) a form of choroidal
neovascularization. PDT or TTT was performed on 46 eyes of 46 patients with PCV; 19 eyes were
treated with TTT (TTT group) and 27 eyes with PDT (PDT group). Best-corrected visual acuity
(BCVA) was significantly better and the fovea was significantly thinner in the PDT group than in the
TTT group after treatment.
Tewari et al. (2007) compared the visual outcomes of photodynamic therapy (PDT) with verteporfin
and transpupillary thermotherapy (TTT) for classic subfoveal choroidal neovascularization (CNVM)
secondary to age-related macular degeneration (ARMD) in 32 eyes. Stabilization or improvement
occurred in 69% of patients undergoing PDT and 50% patients undergoing TTT at six months of
follow-up. The investigators concluded that for short-term preservation of vision in patients of classic
CNVM due to ARMD, PDT seems to be better than TTT if the pre-laser best corrected visual acuity is
greater than 20/63 but both are equally effective if pre-laser best corrected visual acuity is less than
20/63.
Shukla et al. (2008) evaluated transpupillary thermotherapy (TTT) for the treatment of subfoveal focal
leaks in central serous chorioretinopathy (CSC). The study included 39 patients (40 eyes) with CSC of
whom 25 patients (25 eyes) opted for TTT for subfoveal leaks. Fourteen patients (15 eyes) were
followed up without treatment. Minimum follow-up was 6 months. Within 3 months, TTT resulted in
the resolution of the serous detachment in 24 (96%) eyes with a single session; one eye required a
repeat treatment. Eight control eyes demonstrated persisting CSC at the last follow-up. Visual acuity
improved in 23 (92%) treated and five (33%) control eyes; the difference in outcome was statistically
significant. One case developed choroidal neovascularization, which resolved with visual recovery to
20/20 after repeat-TTT. The investigators concluded that TTT resulted in the resolution of CSC with
subfoveal angiographic leaks with significant improvement in visual outcome, in comparison to the
natural history of persistent CSC. The value of this study is limited by the small sample size and short
follow-up.
Mason et al. (2008) conducted a retrospective review of 84 consecutive patients with age-related
macular degeneration who received transpupillary thermotherapy for occult subfoveal choroidal
neovascularization. The study was conducted to determine risk factors for immediate severe vision loss
after transpupillary thermotherapy. Seven cases had severe vision loss and 77 were controls. All
patients were treated with a diode infrared laser. Follow-up was completed on all patients 1, 3, and 6
months after treatment with transpupillary thermotherapy. Transpupillary thermotherapy has a small
but significant risk of immediate severe vision loss in patients with age-related macular degeneration
with occult subfoveal choroidal neovascularization. Statistically significant risk factors include a
subretinal hemorrhage 5 disc areas or greater in size, 9 disc areas or greater of subretinal fluid, and a
laser power greater than 550 mW.
The National Institute for Health and Clinical Excellence (NICE) concluded that clinical evidence on
the safety and efficacy of TTT for age-related macular degeneration was inadequate for TTT to be used
without special arrangement for consent and for audit or research (NICE 2004).
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Professional Societies
The American Academy of Ophthalmology (AAO): The AAO preferred practice pattern document
for age-related macular degeneration does not address transpupillary thermal therapy (AAO, 2008).
Transpupillary Thermotherapy for Ocular Tumors:
Chojniak et al. (2011) evaluated the efficacy of transpupillary thermotherapy (TTT) for the treatment
of small choroidal melanomas. The study was a prospective nonrandomized study of transpupillary
thermotherapy for small (thickness ≤ 4.0 mm and basal diameter ≤ 12 mm) pigmented choroidal
melanomas presenting either growth or risk factors for growth and metastasis. Ophthalmoscopic
aspect, tumor control, visual acuity and complications were evaluated. Twenty-seven patients were
treated; mean age 61 years; mean tumor thickness before treatment was 2.7 mm and base was 8.52
mm. After a mean of three treatment sessions and 45-month follow-up, mean tumor thickness
decreased significantly to 1.34 mm and mean tumor base to 5.48 mm. Complications were observed in
12 patients (44%) and included retinal vascular occlusion, optic disc atrophy, retinal traction, vitreous
hemorrhage, rhegmatogenous retinal detachment, and maculopathy. Lesions touching the optic disc
were associated with a significantly higher rate of disc atrophy after treatment (60% vs. 40%). Visual
acuity remained the same in nine eyes (33%), improved in five (19%) and decreased during the first 6
months after treatment in 13 eyes (48%). Complete tumor control without recurrence was observed in
25 patients (93%). Recurrence at tumor margin was detected in two (7%). All eyes were preserved.
One patient had tumor-related death. According to the investigators, TTT is an effective treatment in
the management of selected small choroidal melanoma. Decrease in visual acuity occurred early after
treatment, mainly as a complication of subfoveal and perifoveal tumor treatment.
Pilotto et al. (2009) compared long-term choroidal vascular changes after iodine-125 brachytherapy
(IBT) versus transpupillary thermotherapy (TTT) used as primary treatment. A total of 95 small
choroidal melanomas were randomized: 49 eyes with TTT and 46 eyes with IBT alone. Mean followup was 56.2 months. Tumor regressed in 45 (92%) TTT-treated vs 45 (98%) IBT-treated eyes
(p=0.397). Four TTT-treated and one IBT-treated tumor recurred. Closure of medium and large
choroidal vessels was observed in 17 (35%) TTT-treated vs 44 (96%) IBT-treated eyes (p<0.001).
Choroidal vascular remodeling was detected in 20 (41%) TTT-treated and 16 (35%) IBT-treated eyes
(p=0.693). Retinochoroidal anastomosis was present in 4 of the 37 (11%) TTT-treated eyes with
patency of medium and large choroidal vessels, but never observed in the IBT-treated eyes, and was
associated with tumor recurrence. Among IBT-treated eyes, segments of choroidal vascular wall ICG
staining and choroidal aneurysmal changes were detected in 30 (65%) and 7 (15%), respectively.
These changes were never detected in TTT-treated cases (p<0.0001 and p=0.015, respectively). The
investigators concluded that the pattern of tumor choroidal vascular changes following IBT and TTT
differs. TTT is less effective in closing all tumor vasculature. The role of long-term choroidal vascular
remodeling observed after these two treatments needs longer follow-up.
Desjardins et al. (2006) conducted a randomized study to determine whether systematic TTT after
proton beam radiotherapy could have a beneficial effect in 151 patients with uveal melanomas. One
half of the patients received proton beam radiotherapy alone (and the other half received the same dose
of proton beam radiotherapy followed by TTT at 1, 6 and 12 months. The median follow-up was 38
months. The patients treated with TTT showed a greater reduction of tumor thickness (p = 0.06), less
retinal detachment at the latest follow-up (p = 0.14) and a lower secondary enucleation rate (p = 0.02).
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Further studies are needed to determine whether TTT could be beneficial to smaller tumors and to
define its optimal dose.
Parrozzani et al. (2008) prospectively evaluated the clinical outcomes of TTT as the primary treatment
of choroidal melanoma in 77 eyes. Follow-up was longer than 36 months. Thirteen (76%)
parapapillary tumors and 55 (92%) non-parapapillary tumors regressed. Nine tumors recurred.
Shields et al. (2002a) conducted a prospective non-comparative interventional case series to evaluate
tumor control and treatment complications following plaque radiotherapy combined with
transpupillary thermotherapy for choroidal melanoma. A total of 270 patients received treatment for
choroidal melanoma using plaque radiotherapy followed by 3 sessions of transpupillary thermotherapy
provided at plaque removal and at 4-month intervals. The 2 main outcome measures included local
tumor recurrence and treatment-related complications. The clinical data regarding patient features,
tumor features, radiotherapy and thermotherapy parameters were analyzed for their effect on the 2
main outcomes using Cox proportional hazards regression models. Prior to treatment, the median base
of the tumor was 11 mm (range, 4-21 mm) and the median thickness was 4 mm (range, 2-9 mm). Most
tumors were located in the posterior pole with a median proximity of 2 mm to the foveola and 2 mm to
the optic disc. The median radiotherapy dose to the tumor apex was 9000 rad. Transpupillary
thermotherapy was applied in 3 sessions at 4-month intervals for a median of 700 mW. The tumor
decreased in thickness to a median of 2.3 mm by 1 year and 2.1 mm by 2 years' follow-up with stable
findings thereafter. Using Kaplan- Meier estimates, tumor recurrence was 2% at 2 years and 3% at 5
years. Risk factors for tumor recurrence included macular location of the tumor epicenter, diffuse
tumor configuration, and tumor margin extending underneath the foveola. Using Kaplan-Meier
estimates, treatment-related complications at 5 years included maculopathy in 18% of the participants,
papillopathy in 38%, macular retinal vascular obstruction in 18%, vitreous hemorrhage in 18%,
rhegmatogenous retinal detachment in 2%, cataract in 6%, and neovascular glaucoma in 7%.
Enucleation for radiation complications was necessary in 3 cases (1%). The investigators concluded
that plaque radiotherapy combined with transpupillary thermotherapy provides excellent local tumor
control with only 3% recurrence at 5 years' follow-up.
Sagoo et al. (2010) evaluated treatment of juxtapapillary choroidal melanoma with plaque radiotherapy
and investigated the role of supplemental transpupillary thermotherapy (TTT) in a retrospective,
comparative case series of 650 consecutive eyes with juxtapapillary choroidal melanoma within 1 mm
of the optic disc. Eyes receiving plaque radiotherapy over a 31-year period from October 1974 to
November 2005 were included in the study. The TTT (n=242) and no TTT (n=307) groups were
analyzed separately and compared. Kaplan-Meier estimates for tumor recurrence, metastasis, and death
were 14%, 11%, and 4% at 5 years and 21%, 24%, and 9% at 10 years, respectively. Eyes treated with
additional TTT showed slight (statistically nonsignificant) reduction in recurrence and metastasis.
Using multivariable analysis, factors predictive of tumor recurrence included foveolar tumor requiring
TTT and greater tumor thickness. Factors predictive of metastasis included greater tumor base and
increasing intraocular pressure. The investigators concluded that plaque radiotherapy for juxtapapillary
melanoma provides local tumor control in approximately 80% of eyes at 10 years. In patients who
received TTT, there was slight but nonsignificant improved local tumor control and lower metastatic
rate. According to the investigators, further randomized, prospective analysis could assist in evaluating
the true benefit of adjunctive TTT in juxtapapillary choroidal melanoma.
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National Cancer Institute (NCI): The NCI states that transpupillary thermotherapy (TTT) has
important limitations that confine its use to very restricted circumstances. The limited ability of TTT to
penetrate thick tumors with sufficient energy restricts its use to small melanomas or tumors of a size
that some ophthalmologists recommend for follow-up without any initial therapy. When used as the
primary therapy, there are relatively high rates of local recurrence and retinal vascular damage.
Recurrence rates are particularly high when the tumor abuts the optic nerve and overhangs the optic
disc. The NCI also states that combined therapy, with ablative laser coagulation or transpupillary
thermotherapy to supplement plaque treatment may be used for medium-sized choroidal melanomas
(NCI, Intraocular (Uveal) Melanoma 2012).
Transpupillary Thermotherapy for Retinoblastomas
Shields et al. (2005) evaluated the effectiveness of chemoreduction alone and chemoreduction with
thermotherapy for macular retinoblastoma in a prospective, nonrandomized, single-center case series.
There were 68 macular retinoblastomas in 62 eyes of 49 patients managed with chemoreduction. All
patients received 6 cycles of intravenous chemoreduction using vincristine, etoposide, and carboplatin.
The patients were then treated according to 1 of 2 approaches: chemoreduction alone with no adjuvant
focal therapy (group A) or chemoreduction combined with adjuvant foveal-sparing thermotherapy to
each macular retinoblastoma (group B). The main outcome measure was tumor recurrence. Of the 68
tumors, 28 were in group A and 40 were in group B. A comparison of both groups revealed that the
tumors were similar with regard to clinical features. Following treatment, Kaplan-Meier estimates
revealed that group A tumors showed recurrence in 25% by 1 year and 35% by 4 years whereas those
in group B showed recurrence in 17% by 1 year and 17% by 4 years. By multivariate analysis, the
most important factors predictive of tumor recurrence were smaller macular tumor size (judged by
percentage of the macula occupied by the tumor), absence of subretinal or vitreous seeds, and
unilateral disease. Tumors most destined for recurrence are small tumors. According to the
investigators, treatment of macular retinoblastoma with chemoreduction plus adjuvant foveal-sparing
thermotherapy provides tumor control of 83% by 4 years, and this is slightly more favorable than
chemoreduction alone, which provides control of 65% by 4 years.
Shields et al. (1999) reported on the results of TTT in 188 retinoblastomas in 80 eyes of 58 patients in
a prospective study. Smaller tumors were managed by thermotherapy alone; larger tumors were
managed by chemoreduction, followed by tumor consolidation with thermotherapy. Complete tumor
regression was achieved in 161 tumors (85.6%). A total of 27 tumors (14.4%) developed recurrence.
The investigators concluded that thermotherapy is effective for relatively small retinoblastomas
without associated vitreous or subretinal seeds. Such tumors are generally best managed by
chemoreduction, followed by plaque brachytherapy or external beam irradiation. However,
supplemental thermotherapy can often be employed in such cases if vitreal or subretinal seeds have
resolved following irradiation. The study also concluded that larger tumors require more intense
treatment than smaller tumors and are at greater risk of ocular complications, such as focal iris atrophy
and focal paraxial lens opacity.
Abramson and Schefler (2004) evaluated 91 retinoblastoma tumors in 22 eyes of 24 patients with TTT
as the primary treatment modality. In this case series, the outcome measures included local tumor
recurrence and failure of TTT, requiring the use of salvage therapies. The mean follow-up from the
time of the first TTT treatment was 21 months. Tumors were defined as cured when no regrowth had
been observed for six months after treatment. A total of 84 tumors (92%) were cured with TTT alone
Page 10 of 23
and seven tumors (8%) required salvage treatments. All seven tumors requiring salvage treatment were
cured without enucleation. The mean number of treatment sessions required for cure was 1.7, with
64% of the tumors requiring only one session. According to the investigators, retinoblastoma tumors
less than 1.5 DD in base diameter can be successfully treated with TTT alone.
National Cancer Institute (NCI): According to the NCI, laser therapy (thermotherapy) may be used as
primary therapy for small retinoblastoma tumors or in combination with chemotherapy for larger
retinoblastoma tumors. Traditional photocoagulation, in which the laser was applied around the tumor,
has given way to thermotherapy. Thermotherapy is delivered directly to the tumor surface via infrared
wavelengths of light. (NCI, Retinoblastoma 2012).
Conjunctival Incision with Placement of a Pharmacologic Agent:
The studies that assessed conjunctival incision with placement of a pharmacologic agent evaluated
posterior juxtascleral placement of anecortave acetate (Alcon, Inc), an angiostatic steroid that is under
investigation for the prevention and treatment of ocular disease. These studies indicate that
conjunctival incision with posterior juxtascleral placement of anecortave acetate depot suspension or
placebo appears be promising (Veritti, 2009; Hayek, 2007; Van de Moere, 2005; Augustin, 2004;
D'Amico, 2003); however, given the small sample sizes and quality of the studies, there is not enough
evidence to support the use of this technique in treating age related macular degeneration.
Geltzer et al. (2007) conducted a review to examine effects of steroids with antiangiogenic properties
in the treatment of neovascular age-related macular degeneration (AMD). The review included
randomized controlled clinical trials of intra- and peri-ocular steroids (intravitreal triamcinolone or
anecortave acetate) in people diagnosed with neovascular AMD. The authors concluded that overall
there is weak evidence as to the benefits and harms of steroids with antiangiogenic properties for
treating neovascular AMD with only three published trials of variable quality. Intravitreal
triamcinolone injection for neovascular AMD does not appear to prevent severe vision loss and is
associated with increased IOP and higher risk of cataract formation. Anecortave acetate 15 mg may
have a mild benefit in stabilizing vision, but further better quality evidence is needed. The role of
steroids in combination with other treatment modalities is yet to be determined.
Slakter et al. (2006) compared 1-year safety and efficacy of anecortave acetate with photodynamic
therapy (PDT) in a prospective, masked, randomized, multicenter, parallel group, active controlled
clinical trial (the Anecortave Acetate Clinical Study). Five hundred thirty patients with age-related
macular degeneration were randomized to treatment with either anecortave acetate 15 mg or PDT. In
the anecortave acetate group, the drug was administered under the Tenon's capsule as a periocular
posterior juxtascleral depot (PJD) at the beginning of the study and at month 6. Percent responders
(patients losing less than 3 lines of vision) in the anecortave acetate and PDT groups were 45% and
49%, respectively. The confidence interval (CI) for the difference ranged from -13.2% favoring PDT
to +5.6% favoring anecortave acetate. The month 12 clinical outcome for anecortave acetate was
improved in patients for whom reflux was controlled and who were treated within the 6-month
treatment window (57% vs. 49%; 95% CI, - 4.3% favoring PDT to +21.7% favoring anecortave
acetate). No serious adverse events related to the study drug were reported in either treatment group.
According to the investigators, the safety and efficacy outcomes in this study demonstrate that the
benefits of anecortave acetate for the treatment of choroidal neovascularization outweigh the risks
associated with either the drug or the PJD administration procedure. In July 2008, Alcon, Inc.
Page 11 of 23
announced that it has terminated the development program designed to evaluate the benefit of
anecortave acetate treatment on the risk for developing sight-threatening choroidal neovascularization
secondary to age-related macular degeneration. The decision followed a planned interim analysis of
studies C-02-60 A and B that was performed after 2,546 patients had completed the 24 month time
point. In this analysis, anecortave acetate showed no effect on the primary or secondary endpoints. See
the following Web site for more information: http://www.medicalnewstoday.com/articles/114883.php
Accessed June 2013.
Epiretinal radiation therapy:
Petrarca et al. (2013) reported the optical coherence tomography (OCT) and fundus fluorescein
angiography (FFA) results of the Macular Epiretinal Brachytherapy in Treated Age-Related Macular
Degeneration study which is a prospective, multicenter, interventional, non-controlled clinical trial.
The trial included 53 eyes of 53 participants with chronic, active neovascular agerelated macular
degeneration (AMD). Participants underwent pars plana vitrectomy with a single 24-gray dose of
epimacular brachytherapy (EMB). The main outcome measures for the study were change in OCT
center-point thickness and angiographic lesion size 12 months after EMB. Based on the results of the
study, the authors concluded that in chronic, active, neovascular AMD, EMB is associated with
nonsignificant changes in center-point thickness and FFA total lesion size over 12 months.
Avila et al. (2011) evaluated the long-term safety and visual acuity outcomes associated with
epimacular strontium 90 brachytherapy combined with intravitreal bevacizumab for the treatment of
subfoveal choroidal neovascularization because of age-related macular degeneration. Thirtyfour
treatment-naive patients with predominantly classic, minimally classic, and occult subfoveal choroidal
neovascularization lesions participated in this prospective, 2-year, nonrandomized multicenter study.
Based on the results of the study, the authors concluded that epimacular brachytherapy shows promise
as a therapeutic option for subfoveal neovascular age-related macular degeneration. The procedure was
safe and well tolerated, with a reasonable risk-benefit profile that warrants further study in larger
subject populations.
A Cochrane systematic evidence review examined the effects of radiotherapy on neovascular agerelated macular degeneration (AMD). All randomized controlled trials in which radiotherapy was
compared to another treatment, sham treatment, low dosage irradiation or no treatment in people with
choroidal neovascularization secondary to AMD were included. Thirteen trials (n=1154) investigated
external beam radiotherapy with dosages ranging from 7.5 to 24 Gy; one additional trial (n=88) used
plaque brachytherapy (15Gy at 1.75mm for 54 minutes/12.6 Gy at 4mm for 11 minutes). Most studies
found effects (not always significant) that favored treatment. Overall there was a small statistically
significant reduction in risk of visual acuity loss in the treatment group. There was considerable
inconsistency between trials and the trials were considered to be at risk of bias, in particular because of
the lack of masking of treatment group. Subgroup analyses did not reveal any significant interactions;
however, there were small numbers of trials in each subgroup (range three to five). There was some
indication that trials with no sham irradiation in the control group reported a greater effect of
treatment. According to the authors, the review did not provide convincing evidence that radiotherapy
is an effective treatment for neovascular AMD. If further trials are to be considered to evaluate
radiotherapy in AMD then adequate masking of the control group must be considered (Evans et al.
2010).
Page 12 of 23
A National Institute for Health and Clinical Excellence (NICE) guidance document states that current
evidence shows radiotherapy for age-related macular degeneration to have little efficacy. There are
also concerns about its safety. It is suitable for use only within good quality research studies approved
by a research ethics committee, specifying the dose of radiation used and with explicit patient consent
(NICE, 2004).
A National Institute for Health and Clinical Excellence (NICE) guidance for epiretinal brachytherapy
for wet age-related macular degeneration states that current evidence on the efficacy of epiretinal
brachytherapy for wet age related macular degeneration (AMD) is inadequate and limited to small
numbers of patients. With regard to safety, vitrectomy has wellrecognized complications and there is a
possibility of subsequent radiation retinopathy. NICE guidance states that this procedure should only
be used in the context of research (NICE 2011).
The phase III, CNV secondary to AMD treated with beta radiation epiretinal therapy (CABERNET)
trial is a multi-center, randomized, controlled study to evaluate the safety and efficacy of beta radiation
epiretinal therapy combined with 2 injections of ranibizumab (Lucentis®) versus ranibizumab alone.
This study has closed recruiting with a projected enrollment of 450 subjects with AMD-related wet
CNV from international locations in addition to 30 sites in the United States. Final data collection for
the primary outcome measure is expected to be completed in 2009. The projected study completion
date is 2011. See the following for more information:
http://www.clinicaltrials.gov/ct2/show/NCT00454389?term+CABERNET&rank+1 . Accessed June
2013.
A phase IV randomized controlled trial comparing macular epiretinal brachytherapy versus
ranibizumab (Lucentis®) only treatment (MERLOT) sponsored by NeoVista is being conducted in the
United Kingdom. The projected study completion date is 2014. See the following for more
information: http://clinicaltrials.gov/ct2/show/NCT01006538 . Accessed June 2013.
Laser Photocoagulation for Macular Drusen:
The largest available randomized controlled trial (RCT) of laser treatment for macular drusen is the
Complications of Age-Related Macular Degeneration Prevention Trial (CAPT). This study enrolled
1052 patients who had large bilateral drusen and randomized one eye to laser treatment and the other
eye to observation. An argon green laser was preferred but lasers with other wavelengths could be used
if an argon green laser was not available. At randomization, the treatment eye received 60 laser burns
of 100-diameter and 100-millisecond duration in a grid pattern between 1500 and 2500 from the foveal
center. Lesions were designed to be barely visible and drusen were not targeted specifically. If
significant reduction of drusen was not apparent after 12 months, a second treatment of 30 burns
specifically targeting drusen was administered in the treatment eye. Of the 1042 patients available 1
year after the initial treatment, 856 (82%) underwent a second laser treatment. At 2 years follow-up,
50% or greater drusen reduction was seen in 34% of treated eyes versus 9% of untreated eyes. Despite
the influence of laser therapy on drusen, at 5 years follow-up, there were no statistically significant
differences between treated and untreated eyes in visual acuity (VA), CNV, geographic atrophy,
contrast threshold, or critical print size. The CAPT Research Group concluded that preventative laser
treatment was neither harmful nor beneficial (Complications of Age-Related Macular Degeneration
Prevention Trial (CAPT) Research Group, 2006).
Page 13 of 23
The results of three additional randomized controlled trials (Friberg, 2006; Maguire, 2003; Owens,
2006) provide strong evidence that current prophylactic laser treatment protocols do not benefit
patients who have macular drusen. None of the reviewed studies found that laser treatment provided a
statistically or clinically significant benefit. Furthermore, these studies concluded that laser therapy
accelerated onset of CNV in patients who have drusen in one eye and CNV or retinal detachment in the
other eye.
A Cochrane review examined the effectiveness and adverse effects of laser photocoagulation of drusen
in AMD. The selected studies for the review included randomized controlled trials (RCTs) of laser
treatment of drusen in AMD in which laser treatment had been compared with no intervention or sham
treatment. Nine studies which randomized 2216 people were selected: four unilateral trials, three
bilateral trials and two trials that included both a unilateral and a bilateral study arm. Overall, the
studies were of moderate quality. Although two (of the nine) studies reported significant drusen
disappearance at two years, photocoagulation did not appear to affect the development of CNV at two
years follow up or the loss of three or more lines of visual acuity. The authors concluded that the
reviewed trials confirmed the clinical observation that laser photocoagulation of drusen leads to their
disappearance. However, there is no evidence that this subsequently results in a reduction in the risk of
developing CNV, geographic atrophy or visual acuity loss (Parodi et al. 2009).
Mojana et al. (2011) evaluated the long-term effect of subthreshold diode laser treatment for drusen.
Eight eyes of four consecutive age-related macular degeneration patients with bilateral drusen
previously treated with subthreshold diode laser were imaged with spectral domain optical coherence
tomography/scanning laser ophthalmoscope. Based on the study results, the investigators concluded
that subthreshold diode laser treatment causes long-term disruption of the retinal photoreceptor layer.
They state further that the concept that subthreshold laser treatment can achieve a selected retinal
pigment epithelium effect without damage to rods and cones may be flawed.
Huang et al. (2011) prospectively evaluated the efficacy and safety of prophylactic laser treatment in
patients with bilateral soft drusen 8 years after treatment. The study included 10 patients with more
than 10 soft drusen (> 125 mm) and best corrected visual acuity ≥ 20/25 in each eye. One eye, with
relatively more drusen, was exposed to an argon laser (514 nm) to achieve a barely visible retinal
lesion. The contralateral eye was used as a control. Fluorescein angiography, Amsler tests, Fourierdomain optical coherence tomography and visual evoked potential tests were carried out 8 years later.
No choroidal neovascularization was seen in the laser-treated eyes or control eyes. There were no
significant differences in visual acuity or P100 latency and amplitude between the laser treated eyes
and contralateral eyes. The thickness of the retinal pigment epithelium of the treated eyes was less than
that of the contralateral eyes. The full retinal thickness in treated eyes was slightly, but insignificantly,
reduced relative to contralateral eyes. The authors concluded that laser treatment was associated with a
reduction in retinal pigment epithelium thickness elevation compared with the contralateral eyes.
Macular function was not impaired. According to the authors, the study was small and therefore the
results should be interpreted with caution.
Additional Search Terms
Posterior juxtascleral depot (PJD)
Page 14 of 23
U.S. FOOD AND DRUG ADMINISTRATION (FDA)
Ophthalmic lasers are regulated by the FDA as Class II devices and many lasers have been approved
via the 510(k) approval process. Ophthalmic diode laser systems that have received 510(k) marketing
clearance for transpupillary thermotherapy include but are not limited to:
 IRIS Medical IQ 810 laser photocoagulator (IRIDEX Corp.) 510(k) approval (K040209)
received 1/30/2004, (See the following Web site for more information:
http://www.accessdata.fda.gov/cdrh_docs/pdf4/K040209.pdf. Accessed June 2013.

Nidex DC - 3000 laser diode photocoagulator (Nidek, Inc.) 510(k) (K903639) approval
received 08/13/1990. (See the following Web site for more information:
http://www.accessdata.fda.gov/cdrh_docs/pdf/K013760.pdf. Accessed June 2013.
A listing of all devices in the same product classification as those above (Product Code HQF and
GEX) is available on the FDA Web site
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm. Accessed June 2013.
The NeoVista Epi-Rad90TM System is accepted by the U.S. Food and Drug Administration (FDA)
under the provisions of an Investigational Device Exemption (IDE) which allows the investigational
device to be used in order to collect safety and effectiveness data required to support a premarket
approval application or a 510(k) submission to the FDA. See the following for
more information: http://pbadupws.nrc.gov/docs/ML0911/ML091140370.pdf Accessed June 2013.
Laser photocoagulation for macular drusen is a procedure and, as such, is not subject to regulation by
the FDA. However, laser devices used to perform this therapy are regulated by the FDA. They are
classified under two product codes, HQB (Ophthalmic Photocoagulator) and HQF (Ophthalmic Laser),
incorporating more than 100 approved devices. An example of an ophthalmic laser used for
photocoagulation of macular drusen is the Iris Medical OcuLight (Iridex Corp.) (Product Code HQF).
This device was approved by the FDA on August 27, 2003. See the following Web site for more
information: http://www.accessdata.fda.gov/cdrh_docs/pdf3/K031665.pdf. Accessed June 2013.
The Implantable Miniature Telescope (IMT) received FDA approval, effective July 1, 2010. This
device is indicated for monocular implantation to improve vision in patients greater than or equal to 75
years of age with stable severe to profound vision impairment (best corrected distance visual acuity
20/160 to 20/800) caused by bilateral central scotomas associated with end-stage age-related macular
degeneration.
Patients must:
 have retinal findings of geographic atrophy or disciform scar with foveal involvement, as
determined by fluorescein angiography
 have evidence of visually significant cataract (greater or equal to Grade 2)
 agree to undergo pre-surgery training and assessment (typically 2 to 4 sessions) with low vision
specialists (optometrist or occupational therapist) in the use of an external telescope sufficient
for patient assessment and for the patient to make an informed decision
Page 15 of 23



achieve at least a 5-letter improvement on the Early Treatment Diabetic Retinopathy Study
(ETDRS) chart with an external telescope
have adequate peripheral vision in the eye not scheduled for surgery
agree to participate in postoperative visual training with a low vision specialist. According to
the FDA approval letter, a post-approval requirement indicates that the manufacturer must 1)
continue follow-up on the patients from its long-term cohort study to provide additional longterm (up to 8 years) safety data and 2) must conduct an additional study of 770 newly enrolled
patients to evaluate adverse events for 5 years after implantation.
See the following Web site for more information:
http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050034a.pdf Accessed June 2013.
According to the FDA’s Summary of Safety and Effectiveness Data, the IMT is contraindicated in
patients with any of the following:
 Stargardt's macular dystrophy.
 central anterior chamber depth (ACD) <3.0 mm; measurement of the ACD should be taken
from the posterior surface of the cornea (endothelium) to the anterior surface of the crystalline
lens.
 the presence of corneal guttata.
 Endothelial cell density (ECD) counts below the following minimum baseline: o
o Age 75 - 84 years with ECD below 2000 cells/mm2
o Age 85 years or older with ECD below 1800 cells/mm2
 cognitive impairment that would interfere with the ability to understand and complete the
Acceptance of Risk and Informed Decision Agreement or prevent proper visual
training/rehabilitation with the device.
 evidence of active choroidal neovascularization (CNV) on fluorescein angiography or treatment
for CNV within the past six months.
 any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
 previous intraocular or cornea surgery of any kind in the operative eye, including any type of
surgery for either refractive or therapeutic purposes.
 prior or expected ophthalmic related surgery within 30 days preceding intraocular telescope
implantation.
 a history of steroid-responsive rise in intraocular pressure, uncontrolled glaucoma, or
preoperative intraocular pressure greater than 22 mm Hg, while on maximum medication.
 known sensitivity to post-operative medications.
 a history of eye rubbing or an ocular condition that predisposes them to eye rubbing.
 the planned operative eye has:
o Myopia greater than 6.0 diopters
o Hyperopia greater than 4.0 diopters
o Axial length less than 21 mm
o A narrow angle (i.e., less than Schaffer grade 2)
o Cornea stromal or endothelial dystrophies, including guttata
o Inflammatory ocular disease
o Zonular weakness/instability of crystalline lens, or pseudoexfoliation
o Diabetic retinopathy
Page 16 of 23
o
o
o
o
o
o
Untreated retinal tears
Retinal vascular disease
Optic nerve disease
A history of retinal detachment
Intraocular tumor
Retinitis pigmentosa.
See the following Web site for more information:
http://www.accessdata.fda.gov/cdrh_docs/pdf5/P050034b.pdf Accessed June 2013.
APPLICABLE CODES
The codes listed in this policy are for reference purposes only. Listing of a service or device code in
this policy does not imply that the service described by this code is a covered or non-covered health
service. Coverage is determined by the benefit document. This list of codes may not be all inclusive.
CPT® Code
0124T
0186T
0190T
0308T
67299
92499
Description
Conjunctival incision with posterior extrascleral placement of
pharmacological agent (does not include supply of medication)
Suprachoroidal delivery of pharmacologic agent (does not include supply of
medication)
Placement of intraocular radiation source applicator (List separately in
addition to primary procedure)
Insertion of ocular radiation source applicator (List separately in addition to
primary procedure)
Unlisted procedure, posterior segment
Unlisted ophthalmological service or procedure
CPT® is a registered trademark of the American Medical Association.
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PROTOCOL HISTORY/REVISION INFORMATION
Date
06/27/2013
07/26/2012
10/27/2011
01/28/2011
09/23/2010
07/24/2009
Action/Description
Corporate Medical Affairs Committee
The foregoing Health Plan of Nevada/Sierra Health & Life Health Operations protocol has been
adopted from an existing UnitedHealthcare coverage determination guideline that was researched,
developed and approved by the UnitedHealthcare Coverage Determination Committee.
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MACULAR DEGENERATION AND OCULAR TUMOR TREATMENT

Transcription

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