Steroids for Early Treatment of Radiation Retinopathy
- Conditions
- Radiation Retinopathy
- Interventions
- Registration Number
- NCT03238157
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- Iris melanoma
- Opaque media
- less than 21 years of age
- Inability to give consent
- Positive pregnancy test
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Fluocinolone Acetonide (FA) implant 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.
- Primary Outcome Measures
Name Time Method Central subfield retinal thickness by OCT scan 24 months Anatomic outcome
- Secondary Outcome Measures
Name Time Method Best corrected visual acuity 24 months Functional outcome Best corrected Visual acuity and Visual field defect
Trial Locations
- Locations (1)
Cole Eye Instiute
🇺🇸Cleveland, Ohio, United States