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Intravitreal Faricimab Injections or Fluocinolone Acetonide (0.19 Mg) Intravitreal Implants Vs Observation for Prevention of VA Loss Due to Radiation Retinopathy
Recruiting
I'm InterestedTrial ID: NCT05844982
Purpose
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.
Official Title
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
Stanford Investigator(s)
Prithvi Mruthyunjaya, MD, MHS
Alan Adler Professor of Ophthalmology and Professor, by courtesy, of Radiation Oncology
Eligibility
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
Intervention(s):
drug: Faricimab
drug: fluocinolone acetonide
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Naz Jehangir