A Randomized Clinical 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 AL)
- Sponsor: Jaeb Center for Health Research
- Principal Investigator: Michael Altaweel, MD
- Study Coordinator: Kris Dietzman
Study Objective:
To 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.
Study Design:
Subjects will be randomized to one of three groups: intravitreal injection with faricimab at randomization and every 3 months, intravitreal implant with fluocinolone acetonide at randomization and at 24 months, or observation.
Inclusion Criteria:
- Primary uveal melanoma (excluding iris melanoma) receiving primary treatment with plaque brachytherapy
- 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
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
Contact Kris Dietzman with questions, (608) 263-9035
For more information about this study, visit clinicaltrials.gov: