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

Regenera Pharma

Status and phase: Completed; Phase 2

Conditions: Optic Nerve Injuries; Non-arteritic Ischemic Optic Neuropathy

Treatments: Drug: RPh201; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02045212

RGN-ON-001

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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22 participants in 2 patient groups, including a placebo group

RPh201

Experimental group

Description:

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

Treatment:

Drug: RPh201

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo