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

Jaeb Center for Health Research

Status and phase: Enrolling; Phase 3

Conditions: Radiation Retinopathy; Visual Impairment

Treatments: Drug: Faricimab; Drug: fluocinolone acetonide

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT05844982

UG1EY014231 (U.S. NIH Grant/Contract)

Protocol AL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

600 participants in 3 patient groups

Intravitreal faricimab

Active Comparator group

Description:

Study eyes assigned to receive faricimab will receive a dose of 6.0 mg of faricimab. Faricimab is supplied in a single use vial.

Treatment:

Drug: Faricimab

Fluocinolone Acetonide Intravitreal Implants

Active Comparator group

Description:

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

Treatment:

Drug: fluocinolone acetonide

Observation

No Intervention group