Trial record 10 of 170 for:    "Optic Nerve Diseases"

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

This study is not yet open for participant recruitment.
Verified January 2014 by Regenera Pharma Ltd
Sponsor:
Information provided by (Responsible Party):
Regenera Pharma Ltd
ClinicalTrials.gov Identifier:
NCT02045212
First received: January 21, 2014
Last updated: January 22, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Non-arteritic Ischemic Optic Neuropathy
Optic Nerve Injuries
Drug: RPh201
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Resource links provided by NLM:


Further study details as provided by Regenera Pharma Ltd:

Primary Outcome Measures:
  • To assess any changes in visual acuity and visual field observed following the treatment [ Time Frame: 26/39 weeks ] [ Designated as safety issue: No ]

    The primary endpoints of this study are to assess any changes in visual acuity and visual field observed following the subcutaneous (SC) administration of RPh201 an overall treatment period of up to 13/26 weeks and at the follow-up visit at 3 month after end of treatment:

    • To assess any changes in visual acuity and visual field observed following the SC administration of RPh201
    • To assess any changes in Visual Evoked Potential observed following the SC administration of RPh201
    • To assess any changes in Optical Coherence Tomography (OCT) observed following the SC administration of RPh201


Secondary Outcome Measures:
  • To demonstrate safety and tolerability of multiple SC doses of RPh201 [ Time Frame: 26/39 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam


Estimated Enrollment: 20
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: RPh201
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02045212

Contacts
Contact: Segal Zvi, MD 04-9107522 zvi.segal@naharia.health.gov.il

Locations
Israel
Ophthalmology Department, Western Galilee-Nahariya Medical Center Not yet recruiting
Nahariya, Israel
Contact: ‪Reut Peled, BA    054-6230889    peledrm@gmail.com   
Principal Investigator: Zvi Segal, MD         
Principal Investigator: Eytan Z Rath, MD         
Sponsors and Collaborators
Regenera Pharma Ltd
Investigators
Principal Investigator: Zvi Segal,, MD Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel
  More Information

No publications provided

Responsible Party: Regenera Pharma Ltd
ClinicalTrials.gov Identifier: NCT02045212     History of Changes
Other Study ID Numbers: RGN-ON-001
Study First Received: January 21, 2014
Last Updated: January 22, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Regenera Pharma Ltd:
Ischemic Optic Neuropathy
Traumatic Neuropathy
Non Arteritic Ischemic Neuropathy (NAION)

Additional relevant MeSH terms:
Optic Nerve Diseases
Optic Neuropathy, Ischemic
Ischemia
Optic Nerve Injuries
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Wounds and Injuries
Pathologic Processes
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Cranial Nerve Injuries
Craniocerebral Trauma
Trauma, Nervous System
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Poisoning
Substance-Related Disorders

ClinicalTrials.gov processed this record on April 22, 2014