Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Condition: Non-arteritic Ischemic Optic Neuropathy; Optic Nerve Injuries
MeSH terms: Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Optic Nerve Injuries; Ischemia
Intervention: RPh201; Placebo
Intervention description: SC injection twice a week during 13/26 weeks; SC injection twice a week during 13/26 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ischemic Optic Neuropathy; Traumatic Neuropathy; Non Arteritic Ischemic Neuropathy (NAION)

Summary:

      The study objectives are to assess any changes in visual acuity and visual field observed
      following the administration of RPh201 during an overall treatment period of at least 13
      consecutive weeks with an option to extended the treatment phase to another 13 weeks (26
      weeks total), and at the follow-up visit at 3 month after end of treatment in patients with
      optic nerve neuropathy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participants, either men or women are ≥ 18 years of age.

          2. Diagnosis of ischemic optic neuropathy unilateral or bilateral:

               1. Traumatic Neuropathy

               2. Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION)

          3. Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15
             degrees or both.

          4. Field of view with a reduction from 10 degrees to one quarter situations functions.

          5. Participant understands the nature of the procedure and provides written informed
             consent prior to any study procedure.

          6. Women of child bearing potential must use adequate birth-control precautions.

        Exclusion Criteria:

          1. Glaucoma

          2. Neuropathy caused by tumors.

          3. Neuropathy caused by infections

          4. Mitochondrial optic neuropathies

          5. Nutritional, Radiation, Toxic optic neuropathies

          6. Retinal diabetic complications

          7. Hereditary optic neuropathies

          8. Patients with complete SCOTOMA beyond three quarters.

          9. Clinical evidence for presence of infection.

         10. Patient is receiving, or has received within one month prior to enrollment
             corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and
             chemotherapy.

         11. Patient has a history of alcohol or drug abuse within the last two years.

         12. Female patients who are pregnant or nursing, or of childbearing potential and are not
             using adequate contraception.

         13. Participation in another clinical trial within 60 days prior to the Screening Visit or
             during this study.

         14. Clinically significant and/or uncontrolled condition or other significant medical
             disease

         15. Clinically significant uncontrolled retinal disease (AMD)