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Recruiting NCT05844982

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

Phase III Interventional Radiation Retinopathy Visual Impairment

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Faricimab, fluocinolone acetonide.
Who it may be relevant to
Registry conditions: Radiation Retinopathy, Visual Impairment. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

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

Primary outcome measures

  • Change in visual acuity from baseline [Time frame: from baseline at 3 years]
  • Loss of 15 or more letters of visual acuity from baseline [Time frame: from baseline at 3 years]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 25 centers
  • Byers Eye Institute at Stanford University — Palo Alto
  • Retina Consultants — Manchester
  • Retina Associates of Florida, LLC — Tampa
  • Emory Eye Center — Atlanta
  • Northwestern Memorial Group — Chicago
  • IL Eye and Ear Infirmary-University of Illinois at Chicago — Chicago
  • Midwest Eye Institute — Indianapolis
  • University of Iowa Department of Ophthalmology and Visual Sciences — Iowa City
  • … and 17 more centers

Identifiers

NCT: NCT05844982 · Protocol AL · UG1EY014231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗