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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJaeb Center for Health Research

About this trial

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 criteria

Qualifiers

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)

Disqualifiers

Opaque media

Inability to undergo fluorescein angiography

Less than 18 years of age

Prior vitrectomy

Trial design

Treatments tested in this trial

  • Faricimab
  • fluocinolone acetonide

Treatment groups

600 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Jaeb Center for Health Research

Lead sponsor

National Eye Institute (NEI)

Collaborator

National Institutes of Health (NIH)

Collaborator

Alimera Sciences

Collaborator

Genentech, Inc.

Collaborator