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

Part of paid clinical trials in Palo Alto, California.

Sponsor
Jaeb Center for Health Research
Study ID
NCT05844982
Phase
PHASE3
Status
Recruiting
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Conditions

  • Radiation Retinopathy
  • Visual Impairment

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Faricimab — DRUG
    6.0 mg intravitreal injection at randomization and every 3 months
  • fluocinolone acetonide — DRUG
    0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months

Study Details

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.

Key Dates

Start date
Nov 21, 2023
Status verified
Sep 2025
Primary completion
Dec 26, 2029
Completion
Dec 26, 2029

Study Design

Enrollment
600 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Intravitreal faricimab
    Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.
  • Active Comparator: Fluocinolone Acetonide Intravitreal Implants
    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
  • No Intervention: Observation

Primary Outcome Measure

Change in visual acuity from baseline [ Time Frame: from baseline at 3 years ]

Central Contacts

Locations (23)

FacilityCityStateZIPSite coordinators
Byers Eye Institute at Stanford UniversityPalo AltoCalifornia94303
Prithvi Mruthyunjaya, MD, MHS
[email protected]
6504988790
Retina ConsultantsManchesterConnecticut06042
Noam Rudnick, MD, PhD
[email protected]
2036458430
Retina Associates of Florida, LLCTampaFlorida33609
Ivan J. Suner, MD
[email protected]
813-875-6373
Emory Eye CenterAtlantaGeorgia30322
Andrew M. Hendrick, MD
[email protected]
4047784261
IL Eye and Ear Infirmary-University of Illinois at ChicagoChicagoIllinois60612
Michael J. Heiferman, MD
[email protected]
(312) 355-3743
Northwestern Memorial GroupChicagoIllinois60611
Randy Bowen, MD
[email protected]
312-695-2567
Midwest Eye InstituteIndianapolisIndiana46290
John Minturn
[email protected]
317-817-1414
University of Iowa Department of Ophthalmology and Visual SciencesIowa CityIowa52242
Elaine M. Binkley, MD
[email protected]
3193563185
Foundation for Vision Research and Retina Specialists of Michigan, P.C.Grand RapidsMichigan49546
Thomas M. Aaberg, Jr, MD
[email protected]
616-954-2020
Associated Retinal Consultants, P.C.Royal OakMichigan48073
Adam Weiner
[email protected]
2482889132
Mayo ClinicRochesterMinnesota55905
Lauren Dalvin, MD
[email protected]
507-538-8119
Retina Research Institute, LLCSt LouisMissouri63128
Bradley T. Smith, MD
[email protected]
314-367-1181
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of MedicineCelvelandOhio44120
Arun D. Singh, MD
[email protected]
216-445-9519
Oregon Health & Science UniversityPortlandOregon97239
Alison H. Skalet, MD, PhD
[email protected]
503-494-3055
Retina-Vitreous Consultants, Inc.MonroevillePennsylvania15146
Robert L. Bergren, MD
[email protected]
412-683-5300
Wills Eye HospitalPhiladelphiaPennsylvania19107
Sara E. Lally, MD
[email protected]
Pittsburgh Clinical Trial ConsortiumSewickleyPennsylvania15143
Pamela P. Rath
[email protected]
4123015326
Retina Consultants of Carolina, PAGreenvilleSouth Carolina29605
Chris S. Bergstrom, MD
[email protected]
864-233-5722
Tennessee Retina, PCNashvilleTennessee37203
David A. Reichstein, MD
[email protected]
6159836000
Retina Consultants of Texas, PABellaireTexas77401
Amy C Schefler, MD
[email protected]
713-524-3434
UT Southwestern Medical CenterDallasTexas75390
Noy Ashkenazy, MD
[email protected]
214-645-2012
Texas Retina AssociatesLubbockTexas79424
Michel Shami, MD
[email protected]
806-792-0066
The Board of Regents of the University of Wisconsin SystemMadisonWisconsin53705
Michael M. Altaweel, MD
[email protected]
608-263-7290

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Byers Eye Institute at Stanford University· Palo Alto, CARetina Consultants· Manchester, CTRetina Associates of Florida, LLC· Tampa, FLEmory Eye Center· Atlanta, GAIL Eye and Ear Infirmary-University of Illinois at Chicago· Chicago, ILNorthwestern Memorial Group· Chicago, IL

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