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Completed

NCT Number: NCT02045212

Safety and 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.

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Key information

Conditions

Non-arteritic Ischemic Optic Neuropathy Cardiovascular Diseases Cranial Nerve Diseases Cranial Nerve Injuries Craniocerebral Trauma Eye Diseases Nervous System Diseases Optic Nerve Diseases Optic Nerve Injuries Optic Neuropathy, Ischemic Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ophthalmology Department, Western Galilee-Nahariya Medical Center

Nahariya, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

RPh201

Drug

SC injection twice a week during 13/26 weeks

Placebo

Drug

SC injection twice a week during 13/26 weeks

Primary outcomes

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

    Time frame: 26/39 weeks

    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.

  2. Changes in Visual Field Observed Following the Treatment

    Time frame: 26 weeks

    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

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

    Time frame: 26 weeks

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

Secondary outcomes

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

    Time frame: 26/39 weeks

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

Sponsors and collaborators

Lead sponsor

Regenera Pharma Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jan 24, 2014
Registry last updated
Mar 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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