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

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Radiation Retinopathy Visual Impairment	Drug: Faricimab Drug: fluocinolone acetonide	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Jun 15, 2023

Anticipated Primary Completion Date :

Jul 15, 2026

Anticipated Study Completion Date :

Jul 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intravitreal faricimab 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 6.0 mg intravitreal injection at randomization and every 3 months
Active Comparator: Fluocinolone Acetonide Intravitreal Implants 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 0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
No Intervention: Observation

Arm

Intervention/Treatment

Active Comparator: Intravitreal faricimab

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

6.0 mg intravitreal injection at randomization and every 3 months

Active Comparator: Fluocinolone Acetonide Intravitreal Implants

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

0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months

No Intervention: Observation

Outcome Measures

Primary Outcome Measures

Change in visual acuity from baseline [from baseline at 3 years]
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.
Loss of 15 or more letters of visual acuity from baseline [from baseline at 3 years]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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