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.
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
- Are there results?
- Not yet: the study is under way
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.
29 sites in 1 country
United States29 sites, 29 recruiting
- 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
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
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 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Jaeb Center for Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH), Alimera Sciences, Genentech, Inc.
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05844982
- Acronym / sponsor ID
- AL / Protocol AL
- Conditions
- Radiation Retinopathy, Visual Impairment
- Keywords
- Visual Acuity, Radiation retinopathy, Faricima, Fluocinolone Acetonide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Jaeb Center for Health ResearchUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI), National Institutes of Health (NIH), Alimera Sciences, Genentech, Inc.
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 26 Dec 2029 (estimated)
- Study completion
- 26 Dec 2029 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intravitreal faricimab | Active comparator | Drug: FaricimabStudy eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial. |
| Fluocinolone Acetonide Intravitreal Implants | Active comparator | Drug: fluocinolone acetonideStudy 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 |
| Observation | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Faricimab6.0 mg intravitreal injection at randomization and every 3 months | Drug | Intravitreal faricimab |
| fluocinolone acetonide0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months | Drug | Fluocinolone Acetonide Intravitreal Implants |
Primary outcome
Change in visual acuity from baseline
Time frame: from baseline at 3 years
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.
Loss of 15 or more letters of visual acuity from baseline
Time frame: from baseline at 3 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cynthia Stockdale, MPH (8139758690, DRCRNET@JAEB.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual acuity from baseline (time frame: from baseline at 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.