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

NCT02045212 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2020-03-19

Study results available
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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

Interventions

DRUG

RPh201

SC injection twice a week during 13/26 weeks

DRUG

Placebo

SC injection twice a week during 13/26 weeks

Sponsors & Collaborators

  • Regenera Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Zvi Segal,, MD · Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-28
Primary Completion
2016-08-31
Completion
2016-12-31

Countries

  • Israel

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02045212 on ClinicalTrials.gov