Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Participants, either men or women are ≥ 18 years of age.
Diagnosis of ischemic optic neuropathy unilateral or bilateral:
1. Traumatic Neuropathy
2. Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION)
Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both.
Field of view with a reduction from 10 degrees to one quarter situations functions.
Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria

Glaucoma
Neuropathy caused by tumors.
Neuropathy caused by infections
Mitochondrial optic neuropathies
Nutritional, Radiation, Toxic optic neuropathies
Retinal diabetic complications
Hereditary optic neuropathies
Patients with complete SCOTOMA beyond three quarters.
Clinical evidence for presence of infection.
Patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
Patient has a history of alcohol or drug abuse within the last two years.
Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
Participation in another clinical trial within 60 days prior to the Screening Visit or during this study.
Clinically significant and/or uncontrolled condition or other significant medical disease
Clinically significant uncontrolled retinal disease (AMD)

Arm && Interventions

Group	Intervention	Description
RPh201	RPh201	3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201
Placebo	Placebo	3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo

Primary Outcome Measures

Name	Time	Method
Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26	26 weeks	TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.
Changes in Visual Field Observed Following the Treatment	26 weeks	Visual field mean deviation (MD) changes from the screening at week 26 using with the HVF 24-2 FASTPAC program using the size III or Size V test stimulus
Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit	26/39 weeks	Best Corrected Visual Acuity (BCVA) was assessed at all the visits, with refraction as necessary. VA measurements were taken in a sitting position at a test distance of 4 meters using early treatment diabetic retinopathy study (ETDRS) charts.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam	26/39 weeks	Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam