Phase 2 N=22 Randomized Triple-blind Treatment

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

Non-arteritic Ischemic Optic Neuropathy · Optic Nerve Injuries

Bottom Line

View on ClinicalTrials.gov: NCT02045212 ↗

Enrolled (actual)

Serious AEs

22.7%

Results posted

Mar 2019

Primary outcome: Primary: Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit — 15; 7; 9; 6 EDTRS Letters

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: RPh201 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Regenera Pharma Ltd
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Increase From Baseline in ETDRS Letters Read at 26 Weeks and Off-drug Follow-up Visit	15; 7; 9; 6	—
PRIMARY Changes in Visual Field Observed Following the Treatment	7.85; 0.84; 0.41; 0.49	—
PRIMARY Changes Mean RNFL Thickness in NAION Eyes Change From Screening to Week 26	-4.6; -1.8	—
SECONDARY Number of Participants With Adverse Events Assessed by Vital Signs, Clinical Laboratory and Physical Exam	0; 1; 0; 1	—

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

Participants, either men or women are ≥ 18 years of age.
Diagnosis of ischemic optic neuropathy unilateral or bilateral:
Traumatic Neuropathy
Ischemic optic neuropathy - Non Arteritic Ischemic Neuropathy (NAION)
Corrected Visual acuity equal or worse than 6/60 or visual field of less than 15 degrees or both.
Field of view with a reduction from 10 degrees to one quarter situations functions.
Participant understands the nature of the procedure and provides written informed consent prior to any study procedure.
Women of child bearing potential must use adequate birth-control precautions.

Exclusion Criteria

Glaucoma
Neuropathy caused by tumors.
Neuropathy caused by infections
Mitochondrial optic neuropathies
Nutritional, Radiation, Toxic optic neuropathies
Retinal diabetic complications
Hereditary optic neuropathies
Patients with complete SCOTOMA beyond three quarters.
Clinical evidence for presence of infection.
Patient is receiving, or has received within one month prior to enrollment corticosteroids, immunosuppressive drugs, cytotoxic agents, radiation therapy and chemotherapy.
Patient has a history of alcohol or drug abuse within the last two years.
Female patients who are pregnant or nursing, or of childbearing potential and are not using adequate contraception.
Participation in another clinical trial within 60 days prior to the Screening Visit or during this study.
Clinically significant and/or uncontrolled condition or other significant medical disease
Clinically significant uncontrolled retinal disease (AMD)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02045212). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.