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

Primary Purpose

Non-arteritic Ischemic Optic Neuropathy, Optic Nerve Injuries

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

RPh201

Placebo

About this trial

This is an interventional treatment trial for Non-arteritic Ischemic Optic Neuropathy focused on measuring Ischemic Optic Neuropathy, Traumatic Neuropathy, Non Arteritic Ischemic Neuropathy (NAION)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Ophthalmology Department, Western Galilee-Nahariya Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RPh201

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

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

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.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT02045212

First Posted

January 21, 2014

Last Updated

March 9, 2020

Sponsor

Regenera Pharma Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02045212

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

August 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regenera Pharma Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-arteritic Ischemic Optic Neuropathy, Optic Nerve Injuries

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

RPh201

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

RPh201

Intervention Description

SC injection twice a week during 13/26 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

SC injection twice a week during 13/26 weeks

Primary Outcome Measure Information:

Title

Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit

Description

Time Frame

26/39 weeks

Title

Changes in Visual Field Observed Following the Treatment

Description

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

Title

Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26

Description

TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

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

Description

Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam

Time Frame

26/39 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zvi Segal,, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmology Department, Western Galilee-Nahariya Medical Center

City

Nahariya

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

31430268

Citation

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.

Results Reference

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

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