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โ† Trials
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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

RecruitingPhase 3Ages 18 Years - anyAllJaeb Center for Health Research
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Key Inclusion Criteria * Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy * Absence of unrelated cause of visual loss * Baseline visual acuity โ‰ฅ 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 โ‰ฅ30 Gy Key Exclusion Criteria * Opaque media * Inability to undergo fluorescein angiography * Less than 18 years of age * Prior vitrectomy * Intraocular pressure (IOP) โ‰ฅ 25 mmHg or history of steroid- induced IOP elevation that required treatment at baseline * IOP โ‰ฅ 25 mmHg at randomization or increase in IOP โ‰ฅ 8 mmHg from baseline to randomization (following steroid challenge
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What it tests

  • Faricimab
  • fluocinolone acetonide
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Where

29 sites
Byers Eye Institute at Stanford University
Palo Alto, United States
Retina Consultants
Manchester, United States
Retina Associates of Florida, LLC
Tampa, United States
Emory Eye Center
Atlanta, United States
Northwestern Memorial Group
Chicago, United States
IL Eye and Ear Infirmary-University of Illinois at Chicago
Chicago, United States
Midwest Eye Institute
Indianapolis, United States
University of Iowa Department of Ophthalmology and Visual Sciences
Iowa City, United States

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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