NCT03238157

Steroids for Early Treatment of Radiation Retinopathy

• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation Retinopathy

Interventions

Type	Name	Description
DRUG	Fluocinolone 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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2017-08-03
• Last updated: 2021-08-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study