Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy

Phase 3

Recruiting

• Conditions: Radiation Retinopathy; Visual Impairment

• Registration Number: NCT05844982
• Lead Sponsor: Jaeb Center for Health Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-4-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Key Inclusion Criteria<br><br> - Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with<br> plaque brachytherapy<br><br> - Absence of unrelated cause of visual loss<br><br> - Baseline visual acuity = 34 letters (20/200 Snellen equivalent or better)<br><br> - Posterior tumor margin >0 mm from the center of the macula (i.e., tumor is NOT under<br> the geometric center of the fovea)<br><br> - Posterior tumor margin >0 mm from the closest disc margin (i.e., tumor is not<br> touching the edge of the optic disc)<br><br> - Calculated total dose to center of the macula =30 Gy<br><br>Key Exclusion Criteria<br><br> - Opaque media<br><br> - Inability to undergo fluorescein angiography<br><br> - Less than 18 years of age<br><br> - Prior vitrectomy<br><br> - Intraocular pressure (IOP) = 25 mmHg or history of steroid- induced IOP elevation<br> that required treatment at baseline<br><br> - IOP = 25 mmHg at randomization or increase in IOP = 8 mmHg from baseline to<br> randomization (following steroid challenge

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in visual acuity from baseline;Loss of 15 or more letters of visual acuity from baseline