Radiation RetinopathyPhase 3ALNCT05844982

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

A Phase 3 study testing Faricimab and fluocinolone acetonide in people with Radiation Retinopathy and Visual Impairment, run by Jaeb Center for Health Research at 29 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Radiation Retinopathy, Visual Impairment
What is being tested?: Faricimab and fluocinolone acetonide
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 29 sitesUnited States
Study dates: 21 Nov 2023to 26 Dec 2029
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

29 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cynthia Stockdale, MPH contact

8139758690

DRCRNET@JAEB.ORG

City, postcode or hospital

Sites recruiting now only

29 sites in 1 country

United States29 sites, 29 recruiting

Emory Eye Center
Atlanta, Georgia, 30322
Andrew M. Hendrick, MD, 4047784261, mafif@emory.edu
Recruiting
Retina Consultants of Texas, PA
Bellaire, Texas, 77401
Amy C Schefler, MD, 713-524-3434, allison.stroh@retinaconsultantstexas.com
Recruiting
Massachusetts Eye and Ear
Boston, Massachusetts, 02214
Ivana K Kim, MD, MBA, 6145733465, Grayson_Hanlon@meei.harvard.edu
Recruiting
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Celveland, Ohio, 44120
Arun D. Singh, MD, 216-445-9519, shephen@ccf.org
Recruiting
Northwestern Memorial Group
Chicago, Illinois, 60611
Randy Bowen, MD, 312-695-2567, madison.wood@northwestern.edu
Recruiting
IL Eye and Ear Infirmary-University of Illinois at Chicago
Chicago, Illinois, 60612
Michael J. Heiferman, MD, (312) 355-3743, annaong@uic.edu
Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75390
Noy Ashkenazy, MD, 214-645-2012, norma.ortegon@utsouthwestern.edu
Recruiting
Duke Eye Center
Durham, North Carolina, 27710
Arpita Maniar, MD, 9196813937, jessica.baker105@duke.edu
Recruiting
Foundation for Vision Research and Retina Specialists of Michigan, P.C.
Grand Rapids, Michigan, 49546
Thomas M. Aaberg, Jr, MD, holly@fvr.org
616-954-2020
Recruiting
Retina Consultants of Carolina, PA
Greenville, South Carolina, 29605
Chris S. Bergstrom, MD, 864-233-5722, Lfrazier@retina-consultants.com
Recruiting
Southeastern Retina Associates
Hixson, Tennessee, 37343
Asghar A. Haider, 423-756-1002, kschratter@seretina.com
Recruiting
Eye Cancer Associates of Texas
Houston, Texas, 77057
Amy C Schefler, MD, 8332011515, william.thompson@eyecancertx.com
Recruiting
Midwest Eye Institute
Indianapolis, Indiana, 46290
John Minturn, 317-817-1414, haydenb@midwesteye.com
Recruiting
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, Iowa, 52242
Elaine M. Binkley, MD, 3193563185, mary-m-mccormick@uiowa.edu
Recruiting
University of Kentucky Advanced Eye Care
Lexington, Kentucky, 40508
Aditya Bansal, 8595623570, evelyn.Gonzalez@uky.edu
Recruiting
Texas Retina Associates
Lubbock, Texas, 79424
Michel Shami, MD, 806-792-0066, lbrannan@texasretina.com
Recruiting
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, 53705
Michael M. Altaweel, MD, 608-263-7290, kadietzman@wisc.edu
Recruiting
Retina Consultants
Manchester, Connecticut, 06042
Noam Rudnick, MD, PhD, 2036458430, cdwy@retinact.com
Recruiting
Retina-Vitreous Consultants, Inc.
Monroeville, Pennsylvania, 15146
Robert L. Bergren, MD, 412-683-5300, brookea@retinapittsburgh.com
Recruiting
Tennessee Retina, PC
Nashville, Tennessee, 37203
David A. Reichstein, MD, 6159836000, apecora@tnretina.com
Recruiting
Byers Eye Institute at Stanford University
Palo Alto, California, 94303
Prithvi Mruthyunjaya, MD, MHS, 6504988790, moniquenguyen92@stanford.edu
Recruiting
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107
Sara E. Lally, MD, lisac@shields.md
Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Alison H. Skalet, MD, PhD, 503-494-3055, lundquia@ohsu.edu
Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Lauren Dalvin, MD, 507-538-8119, wernimont.suzanne@mayo.edu
Recruiting
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
Adam Weiner, 2482889132, dgedvilas@arcpc.net
Recruiting
Pittsburgh Clinical Trial Consortium
Sewickley, Pennsylvania, 15143
Pamela P. Rath, 4123015326, franco@pghtrials.com
Recruiting
Washington University Ophthalmology
St Louis, Missouri, 63110
Kisha Piggott, Md, PhD, 314-286-2946, squirin@wustl.edu
Recruiting
Retina Research Institute, LLC
St Louis, Missouri, 63128
Bradley T. Smith, MD, 314-367-1181, rhonda.weeks@rc-stl.com
Recruiting
Retina Associates of Florida, LLC
Tampa, Florida, 33609
Ivan J. Suner, MD, 813-875-6373, retinascs@gmail.com
Recruiting

Other trials in United States

About this study

Official title: 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

Read the detailed description

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.

Conditions: Radiation Retinopathy, Visual Impairment
Being tested: Faricimab, fluocinolone acetonide
Keywords: Visual Acuity, Radiation retinopathy, Faricima, Fluocinolone Acetonide
Medical subject headings: Vision Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT05844982
Study group	Role	What they receive
Intravitreal faricimab	Active comparator	Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial. Receives: Drug: Faricimab
Fluocinolone Acetonide Intravitreal Implants	Active comparator	Study eyes assigned to receive fluocinolone acetonide intravitreal implant will receive a dose of 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien). The implant is supplied in a sterile single use applicator with a 25-gauge needle Receives: Drug: fluocinolone acetonide
Observation	No intervention	Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: from baseline at 3 years
Loss of 15 or more letters of 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.
Measured: from baseline at 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202326 Dec 2029

First posted6 May 2023
Study start21 Nov 2023
Primary completion26 Dec 2029 (estimated)
Study completion26 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Radiation RetinopathyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 600 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05844982
Sponsor's protocol ID: Protocol AL
Other IDs: UG1EY014231
Acronym: AL
Status last verified: Oct 2026
First submitted: 25 Apr 2023
Last updated: 23 Oct 2026
Results posted: No
FDA-regulated drug: Yes
FDA-regulated device: No