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

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

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 Overview

• Status: Completed
• Conditions: Non-arteritic Ischemic Optic Neuropathy; Optic Nerve Injuries
• Intervention / Treatment: Drug: RPh201; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel
    • Ophthalmology Department, Western Galilee-Nahariya Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Regenera Pharma Ltd
• Investigators: Principal Investigator: Zvi Segal,, MD, Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel

Publications and helpful links

General Publications

• Rath EZ, Hazan Z, Adamsky K, Solomon A, Segal ZI, Levin LA. Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2019 Sep;39(3):291-298. doi: 10.1097/WNO.0000000000000786.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 22, 2014
• First Posted (Estimate): January 24, 2014

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 9, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Ischemic Optic Neuropathy; Traumatic Neuropathy; Non Arteritic Ischemic Neuropathy (NAION)
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Wounds and Injuries; Neuromuscular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Cranial Nerve Diseases; Cranial Nerve Injuries; Ischemia; Peripheral Nervous System Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Optic Nerve Injuries
• Other Study ID Numbers: RGN-ON-001