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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Non-arteritic Ischemic Optic Neuropathy Optic Nerve Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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RPh201

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

Group Type EXPERIMENTAL

RPh201

Intervention Type DRUG

SC injection twice a week during 13/26 weeks

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

SC injection twice a week during 13/26 weeks

Interventions

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RPh201

SC injection twice a week during 13/26 weeks

Intervention Type DRUG

Placebo

SC injection twice a week during 13/26 weeks

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No