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

NCT05844982 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-18

No results posted yet for this study

Summary

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.

Conditions

  • Radiation Retinopathy
  • Visual Impairment

Interventions

DRUG

Faricimab

6.0 mg intravitreal injection at randomization and every 3 months

DRUG

fluocinolone acetonide

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

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • National Institutes of Health (NIH)

    collaborator NIH

  • Alimera Sciences

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-21
Primary Completion
2029-12-26
Completion
2029-12-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05844982 on ClinicalTrials.gov