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

NCT02045212 | Completed Phase 2 Results

• 1 other identifier: RGN-ON-001
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-arteritic Ischemic Optic Neuropathy; Optic Nerve Injuries

Keywords

Ischemic Optic Neuropathy; Traumatic Neuropathy; Non Arteritic Ischemic Neuropathy (NAION)

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam

  26/39 weeks

Study Arms (2)

RPh201

EXPERIMENTAL

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

Drug: RPh201

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RPh201 DRUG

SC injection twice a week during 13/26 weeks

RPh201

Placebo DRUG

SC injection twice a week during 13/26 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Regenera Pharma Ltd: lead

Study Sites (1)

Ophthalmology Department, Western Galilee-Nahariya Medical Center

Nahariya, Israel

Location

Related Publications (1)

• 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.

  PMID: 31430268 BACKGROUND

MeSH Terms

Conditions

Optic Nerve Injuries; Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases; Wounds and Injuries; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr Konstantin Adamsky
• Organization: Regenera Pharma Ltd

kostia@Regenerapharma.com

+972 8 9316306

Study Officials

• Zvi Segal,, MD

  Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 24, 2014
• Study Start: February 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 19, 2020
• Results First Posted: March 1, 2019

Record last verified: 2020-03

Locations

IL (1)