Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Regenera Pharma Ltd

Intervention(s):

  • Drug: RPh201
  • Other: Placebo

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

50 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Mariana Nunez
650-497-7846
Recruiting