Steroids for Early Treatment of Radiation Retinopathy

Study Overview
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Brief Summary
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Radiation retinopathy is a known complication of ocular radiation therapy. To date there is no known effective treatment. In addition to their anti-vascular endothelial growth factor (VEGF) properties, corticosteroids decrease the retinal capillary permeability by increasing the activity/density of tight junctions and acute inflammatory effects of radiation in various tissues.

Detailed Description
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The purpose of the project is threefold: To study the natural history of radiation retinopathy using advanced imaging techniques. A combination of macular OCT to evaluate for edema, OCT angiography to evaluate for macular and peri-papillary ischemia and wide-field angiography for peripheral ischemia and leakage. Potential role of OCT angiography in radiation retinopathy will be evaluated by comparison to other eye (control) and FA. Currently there is no consensus on effective management strategy for radiation retinopathy. Patients in the interventional will be prospectively followed to study efficacy of steroids for early treatment of radiation retinopathy while comparing the multimodal therapeutic approach in a randomized trial. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.

Official Title
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Steroids for Early Treatment of Radiation Retinopathy

Conditions
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Radiation Retinopathy

Intervention / Treatment
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* Drug: Fluocinolone Acetonide (FA) implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary uveal melanoma Primary treatment with plaque brachytherapy Baseline visual acuity 20/200 or better Posterior tumor margin >1.50 mm from the center of the macula Posterior tumor margin > 1.50 mm from the closest disc margin Calculated total dose to center of the macula >40 Gy Exclusion Criteria: Iris melanoma Opaque media less than 21 years of age Inability to give consent Positive pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observation<br>The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula. These at risk patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to either observation (2:1) (standard of care). | |
| Active Comparator: Intervention<br>The study will only include those patients that are ascertained be at more than 50% risk for vision loss (20/200 or worse at 3 years) because of total radiation dose of >40 Gy to the center of the macula.1 These at risk patients included in the study will receive intravitreal triamcinolone (4 mg in 0.1 ml) injected at the time of plaque removal. If lack of IOP rise (30 mm Hg or more) at 3 months, then randomized to intravitreal Fluocinolone Acetonide (FA) implant. | Drug: Fluocinolone Acetonide (FA) implant<br>* Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.<br>* Other names: Steroid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central subfield retinal thickness by OCT scan | Anatomic outcome | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity | Functional outcome Best corrected Visual acuity and Visual field defect | 24 months |