REGENERA Pharma, Ltd. is currently enrolling patients in a study designed for patients who were affected by NAION for >= 1 year. 

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Study title: "A Double-Masked Clinical study Evaluating the Efficacy and safety of RPh201 Treatment in Participants with Previous NAION"

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Protocol Number: RGN-ON-002

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Study Drug: RPh201; Given as subcutaneous injections twice a week for a duration of 6 months. Made from gum mastic. 

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INCLUSION CRITERIA

1. Age of 50 years old or older at the time of the diagnosis of NAION in the study eye

2. Participant must understand the nature of the procedure and provide written informed consent

3. Must have a confirmed diagnosis of NAION > or = 12 months prior to inclusion (documented disc swelling by an ophthalmologist or neuro-ophthalmologist)

4. Study eye must have disc pallor

5. Study eye must have stable visual acuity

6. The participant must be able to read a minimum of 20 and maximum of 66 letters on EVA chart (BCVA)

7. The participant must have a HVF 24-2 SITA standard (size III) with a MD of -5dB or worse in the study eye. 

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EXCLUSION CRITERIA

1. Treatment for cancer <12 months before enrollment, past dx of metastatic cancer, cancer adjacent to the visual pathways

2. Surgery requiring general anesthesia within 30 days of enrollment

3. Pregnancy or woman of child-bearing age without an acceptable method of contraception 

4. Patient is breast feeding or is planning to breast feed

5. Patient has participated in another clinical trial within 60 days of enrollment. 

6. Patient has received corticosteroids (except topical, injection into joints, inhalers) or immunosppressive drugs within 3 months of enrollment

7. Patient has a medical, social or psychosocial condition that in the judgment of the clinical would preclude them from completing the study. 

8. Known allergy to cottonseed oil

9. Patient is planning to move outside the study site / not near to another study site

10. Patient cannot self administer or have someone else administer the study medication

11. Patient has one/many of the following laboratory test results: Elevated ESR, platelets >400 000/mm3, CRP >2x upper limit of the laboratory, severe anemia (Hb<10)

12. Patient has symptoms, signs or diagnosis of GCA at any time

13. Patient has had treatment with drugs that have a potential neuroprotective or neurotoxic effect (ethambutol, amiodarone, hydroxychloroquine, brimonidine, fingolimod) within 6 months prior to enrollment

14. Patient has any other optic neuropathies in either/both eyes 

15. Participant has systemic inflammatory or infectious disease associated with optic neuropathy or ocular disease.

16. Participant has a history of uveitis in the study eye within the last 10 years.

17. Participant’s study eye has an ocular condition that appears consistent with a reduction in visual acuity to 20/25, diabetic retinopathy beyond mild non-proliferative diabetic retinopathy not involving the macula, or vision-threatening macula disease.

18. Participant has a visual field defect with homonymous non-altitudinal features or a defect that respects the vertical meridian.