Last updated on January 2020

Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Nonarteritic Anterior Ischemic Optic Neuropathy
  • Age: Between 50 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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