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

Launched by JAEB CENTER FOR HEALTH RESEARCH · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how effective two different treatments, intravitreal faricimab injections and fluocinolone acetonide implants, are in preventing vision loss caused by radiation retinopathy after patients have received a specific type of radiation therapy for choroidal melanoma (a type of eye cancer). The trial is comparing these treatments to simply monitoring the patients (observation) to see which approach helps maintain better long-term vision.

To be eligible for this trial, participants must be adults aged 18 and older who have been treated for primary uveal melanoma with plaque brachytherapy (a form of localized radiation therapy) and have a certain level of vision. They should not have any other reasons for vision loss and must meet specific criteria about the location of their tumor. If you join the study, you can expect to receive either one of the treatments or just be observed over time, while doctors closely monitor your vision and overall eye health. The trial aims to gather important information that can help improve treatment options for patients with similar conditions in the future.

Gender

ALL

Eligibility 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