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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Radiation Retinopathy, Visual Impairment

Intervention / Treatment
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* Drug: Faricimab
* Drug: fluocinolone acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravitreal faricimab<br>Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial. | Drug: Faricimab<br>* 6.0 mg intravitreal injection at randomization and every 3 months<br>|
| Active Comparator: Fluocinolone Acetonide Intravitreal Implants<br>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 | Drug: fluocinolone acetonide<br>* 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months<br>|
| No Intervention: Observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity from baseline | Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart. | from baseline at 3 years | 
| Loss of 15 or more letters of visual acuity from baseline | Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart. | from baseline at 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Visual Acuity, Radiation retinopathy, Faricima, Fluocinolone Acetonide