Clinical Trial Details
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Phase IIIInterventional
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
Protocol: 2025P011905NCT: NCT05844982
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.
Eligibility
| Ages | 18 Years and older |
| Sex | All |
| Healthy Volunteers | No |
| Age Groups | Adult, Older Adult |
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