Steroids for Early Treatment of Radiation Retinopathy

• Status: Withdrawn
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Fluocinolone Acetonide

Criteria

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