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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02045212
Recruitment Status : Completed
First Posted : January 24, 2014
Results First Posted : March 1, 2019
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Regenera Pharma Ltd

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.

Condition or disease Intervention/treatment Phase
Non-arteritic Ischemic Optic Neuropathy Optic Nerve Injuries Drug: RPh201 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Study Start Date : February 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : December 2016


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045212


Locations
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Israel
Ophthalmology Department, Western Galilee-Nahariya Medical Center
Nahariya, Israel
Sponsors and Collaborators
Regenera Pharma Ltd
Investigators
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Principal Investigator: Zvi Segal,, MD Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Regenera Pharma Ltd
ClinicalTrials.gov Identifier: NCT02045212     History of Changes
Other Study ID Numbers: RGN-ON-001
First Posted: January 24, 2014    Key Record Dates
Results First Posted: March 1, 2019
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Regenera Pharma Ltd:
Ischemic Optic Neuropathy
Traumatic Neuropathy
Non Arteritic Ischemic Neuropathy (NAION)
Additional relevant MeSH terms:
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Peripheral Nervous System Diseases
Optic Nerve Diseases
Optic Neuritis
Optic Neuropathy, Ischemic
Optic Nerve Injuries
Ischemia
Pathologic Processes
Neuromuscular Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries