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

Non-arteritic Ischemic Optic Neuropathy Clinical Trial

Official title:

A Preliminary Double Blind Clinical Study, Efficacy Study of RPh201 Treatment of Ischemic Optic Neuropathy (ION).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02045212
• Other study ID #: RGN-ON-001
• Status: Completed
• Phase: Phase 2
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: March 2020
• Source: Regenera Pharma Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ischemia
• Non-arteritic Ischemic Optic Neuropathy
• Optic Nerve Diseases
• Optic Nerve Injuries
• Optic Neuropathy, Ischemic
• Peripheral Nervous System Diseases

Intervention

Drug:
• RPh201
SC injection twice a week during 13/26 weeks
• Placebo
SC injection twice a week during 13/26 weeks

Locations

Country	Name	City	State
Israel	Ophthalmology Department, Western Galilee-Nahariya Medical Center	Nahariya

Sponsors (1)

Lead Sponsor	Collaborator
Regenera Pharma Ltd

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit	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.	26/39 weeks
Primary	Changes in Visual Field Observed Following the Treatment	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	26 weeks
Primary	Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26	TMean RNFL thickness measured by OCT. The data are in microns, as measured with an Opko OCT machine.	26 weeks
Secondary	Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam	Safety and tolerability multiple ascending SC doses as assessed by adverse events, vital signs, clinical laboratory and physical exam	26/39 weeks