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

Phase 3RecruitingNCT05844982

Jaeb Center for Health Research600 enrolled

Overview

This randomized controlled trial will evaluate the effect of intravitreal faricimab or fluocinolone acetonide (FAc) intravitreal implant compared with observation on long-term visual acuity following treatment of choroidal melanoma with iodine-125 plaque brachytherapy.

The primary objectives are to compare long-term visual acuity outcomes in eyes that receive repeated treatment with faricimab or fluocinolone acetonide intravitreal implants with those observed initially and treated only if macular edema (ME) develops. The secondary objectives are to determine if repeated treatment with faricimab or fluocinolone acetonide intravitreal implants versus observation can prevent or alter the course of ME from radiation retinopathy and to evaluate the natural history of radiation retinopathy with multimodal imaging including widefield color photographs, widefield fluorescein angiography and OCTA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

600

Conditions

Radiation Retinopathy Visual Impairment

Interventions

FaricimabDRUG

6.0 mg intravitreal injection at randomization and every 3 months

fluocinolone acetonideDRUG

0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (22)

Byers Eye Institute at Stanford University

Outcomes

Primary Outcomes

Change in visual acuity from baseline

Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

Time frame: from baseline at 3 years

Loss of 15 or more letters of visual acuity from baseline

Time frame: from baseline at 3 years

Central Contacts

Cynthia Stockdale, MPH

CONTACT

8139758690 DRCRNET@JAEB.ORG

Data from ClinicalTrials.gov

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