Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)
Trial ID or NCT#
This study is designed as a double-masked, randomized, placebo-controlled, pivotal, clinical study to evaluate the efficacy and safety of subcutaneous (SC) administration of RPh201 in participants with previous NAION. All participants enrolled in the study will have a documented history of NAION for at least 12 months and at most, five years prior to enrollment.
A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION
- - The participant must be 50 years of age or older at the time of the NAION episode in the study eye.
- - The participant has a definitive clinical diagnosis of NAION in the study eye that developed at least 12 months before randomization.
- - The participant's study eye must have stable visual acuity.
- - Using the study eye, the participant must read at least 20 and at most 66 EVA letters with best-corrected vision.
- - The participant's study eye must have a HVF 24-2 Swedish Interactive Testing Algorithm (SITA) Standard visual field using spot size III with mean deviation -5 dB or worse and with a visual field defect compatible with NAION in the study eye.
- - The participant has had treatment with drugs that have potential neuroprotective or toxic effects on the optic nerve or retina (e.g., ethambutol, amiodarone, linezolid, hydroxychloroquine, fingolimod, brimonidine) within 6 months prior to enrollment.
- - The participant has been receiving or has received within three months prior to enrollment, corticosteroids (except topical steroids, steroid inhalers or intermittent injections into a joint or back), or immunosuppressive drugs.
- - The participant has a known allergy to cottonseed oil.
- - The participant has presence of other optic neuropathies (e.g., optic neuritis or glaucoma) in either or both eyes.
- - The participant has systemic inflammatory or infectious disease associated with optic neuropathy or ocular disease.
- - The participant has a history of uveitis in the study eye within the last 10 years.
- - The participant's study eye has an ocular condition that appears consistent with a reduction in visual acuity to <20/25, diabetic retinopathy beyond mild non-proliferative diabetic retinopathy not involving the macula, or vision-threatening macula disease.
- - The participant has a visual field defect with homonymous non-altitudinal features or a defect that respects the vertical meridian.
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