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

Study Overview
=================
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.

Official Title
-----------------
A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Conditions
-----------------
Non-arteritic Ischemic Optic Neuropathy, Optic Nerve Injuries

Intervention / Treatment
-----------------
* Drug: RPh201
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants, either men or women are ≥ 18 years of age. Diagnosis of ischemic optic neuropathy unilateral or bilateral: Traumatic Neuropathy 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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RPh201<br>3/6 month treatment schedule, consisting of bi-weekly SC administration of the RPh201 | Drug: RPh201<br>* SC injection twice a week during 13/26 weeks<br>|
| Placebo Comparator: Placebo<br>3/6 month treatment schedule, consisting of bi-weekly SC administration of the Placebo | Drug: Placebo<br>* SC injection twice a week during 13/26 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit | 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. | 26/39 weeks | 
| Changes in Visual Field Observed Following the Treatment | 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 | 26 weeks | 
| Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26 | TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine. | 26 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non Arteritic Ischemic Neuropathy (NAION), Ischemic Optic Neuropathy, Traumatic Neuropathy