Radiation Retinopathy
Conditions
Brief summary
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
The purpose of the project is threefold: 1. 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. 2. 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. 3. Patients in the observational arm will be prospectively followed while comparing the multimodal therapeutic approach in a randomized trial.
Interventions
DRUGFluocinolone Acetonide (FA) implant
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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized to either observation (2:1) (standard of care) or intravitreal Fluocinolone Acetonide (FA) implant
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central subfield retinal thickness by OCT scan | 24 months | Anatomic outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Best corrected visual acuity | 24 months | Functional outcome Best corrected Visual acuity and Visual field defect |
Other
| Measure | Time frame | Description |
|---|---|---|
| Need for standard of care intervention | 24 months | standard of care intervention with laser photocoagulation and/ or anti VEGF agents |
Countries
United States
Outcome results
None listed