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

NCT05844982

RecruitingPhase 3

Sponsor: Jaeb Center for Health Research

Conditions: Radiation Retinopathy, Visual Impairment

Interventions: Faricimab, fluocinolone acetonide

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 ≥ 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

Key Exclusion Criteria

* 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
Locations (27)
  • Palo Alto, California, United States
  • Manchester, Connecticut, United States
  • Tampa, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Lexington, Kentucky, United States
  • Boston, Massachusetts, United States
  • Grand Rapids, Michigan, United States
  • Royal Oak, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Celveland, Ohio, United States
  • Portland, Oregon, United States
  • Monroeville, Pennsylvania, United States
  • Philadelphia, Pennsylvania, United States
  • Sewickley, Pennsylvania, United States
  • Greenville, South Carolina, United States
  • Hixson, Tennessee, United States
  • Nashville, Tennessee, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • Lubbock, Texas, United States
  • Madison, Wisconsin, United States