Clinical trial NCT02045212: Safety and Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Official title: A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-arteritic Ischemic Optic Neuropathy
Optic Nerve Injuries
Keywords: Ischemic Optic Neuropathy
Traumatic Neuropathy
Non Arteritic Ischemic Neuropathy (NAION)
Lead sponsor: Regenera Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2014-01-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit
timeFrame: 26/39 weeks
measure: Changes in Visual Field Observed Following the Treatment
timeFrame: 26 weeks
measure: Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam
timeFrame: 26/39 weeks
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Ophthalmology Department, Western Galilee-Nahariya Medical Center
Study officials:
affiliation: Head of the Ophthalmology Department, Western Galilee-Nahariya Medical Center Nahariya, Israel
name: Zvi Segal,, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rath EZ, Hazan Z, Adamsky K, Solomon A, Segal ZI, Levin LA. Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy. J Neuroophthalmol. 2019 Sep;39(3):291-298. doi: 10.1097/WNO.0000000000000786.