RecruitingPhase 3NCT05844982

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

A Trial Evaluating Intravitreal Faricimab (6.0 mg) Injections or Fluocinolone Acetonide (0.19 mg Intravitreal Implants vs Observation for Prevention of Visual Acuity Loss Due to Radiation Retinopathy

Sponsor

Jaeb Center for Health Research

Enrollment

600 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

Visual Impairment Radiation Retinopathy

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Faricimab and a drug called fluocinolone acetonide for people with radiation retinopathy and visual impairment. The study is currently recruiting participants at 25 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGFaricimab

6.0 mg intravitreal injection at randomization and every 3 months

DRUGfluocinolone acetonide

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

Locations(27)

Byers Eye Institute at Stanford University

Palo Alto, California, United States

Retina Consultants

Manchester, Connecticut, United States

Retina Associates of Florida, LLC

Tampa, Florida, United States

Emory Eye Center

Atlanta, Georgia, United States

Northwestern Memorial Group

Chicago, Illinois, United States

IL Eye and Ear Infirmary-University of Illinois at Chicago

Chicago, Illinois, United States

Midwest Eye Institute

Indianapolis, Indiana, United States

University of Iowa Department of Ophthalmology and Visual Sciences

Iowa City, Iowa, United States

University of Kentucky Advanced Eye Care

Lexington, Kentucky, United States

Massachusetts Eye and Ear

Boston, Massachusetts, United States

Foundation for Vision Research and Retina Specialists of Michigan, P.C.

Grand Rapids, Michigan, United States

Associated Retinal Consultants, P.C.

Royal Oak, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University Ophthalmology

St Louis, Missouri, United States

Retina Research Institute, LLC

St Louis, Missouri, United States

The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine

Celveland, Ohio, United States

Oregon Health & Science University

Portland, Oregon, United States

Retina-Vitreous Consultants, Inc.

Monroeville, Pennsylvania, United States

Wills Eye Hospital

Philadelphia, Pennsylvania, United States

Pittsburgh Clinical Trial Consortium

Sewickley, Pennsylvania, United States

Retina Consultants of Carolina, PA

Greenville, South Carolina, United States

Southeastern Retina Associates

Hixson, Tennessee, United States

Tennessee Retina, PC

Nashville, Tennessee, United States

Retina Consultants of Texas, PA

Bellaire, Texas, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Texas Retina Associates

Lubbock, Texas, United States

The Board of Regents of the University of Wisconsin System

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05844982

Related Trials

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2

NCT069345771 location

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

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(27)

Related Trials

Touching the World With a Cane: Cognitive and Neural Processes

Hemianopsia Rehabilitation After Stroke or Brain Injury

Improving Visual Field Deficits With Noninvasive Brain Stimulation

Visual Frailty in Ageing

Michigan Screening and Intervention for Glaucoma and Eye Health Through Telemedicine (SIGHT) 2