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

Phase 2CompletedNCT02045212

Regenera Pharma Ltd22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-arteritic Ischemic Optic Neuropathy Optic Nerve Injuries

Interventions

RPh201DRUG

SC injection twice a week during 13/26 weeks

PlaceboDRUG

SC injection twice a week during 13/26 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

Ophthalmology Department, Western Galilee-Nahariya Medical Center

Nahariya, Israel

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: 26 weeks

Secondary Outcomes

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

Time frame: 26/39 weeks

Data from ClinicalTrials.gov

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