Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 mg) Intravitreal Implants vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
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
Jaeb Center for Health Research
600 participants
Nov 21, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria6
- 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
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Interventions
6.0 mg intravitreal injection at randomization and every 3 months
0.19 mg fluocinolone acetonide intravitreal implant (Iluvien) at randomization and at 24 months
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT05844982