NCT03547206

Efficacy & Safety of RPh201 Treatment in Patients With Previous Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 165 (actual)
• Sponsor: Regenera Pharma Ltd · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is designed as a double-masked, randomized, placebo-controlled, clinical study to evaluate the efficacy and safety of subcutaneous (SC) administration of RPh201 in participants with previous NAION. All participants enrolled in Cohort A of the study will have a documented history of NAION for at least 12 months and at most, five years prior to enrollment. Participants enrolled in Cohort B of the study will have a documented history of NAION for at least 6 months and at most, three years prior to enrollment.

Detailed description

This study is designed as a double-masked, randomized, placebo-controlled, clinical study to evaluate the efficacy and safety of SC administration of RPh201 in participants with previous NAION. Following a screening phase of 1-8 weeks, participants will attend a baseline visit in which they will undergo testing and visual function assessments. Participants then will be randomized to receive RPh201 or control. Cohort A After randomization, participants will begin a 26-week schedule consisting of twice-weekly treatment. Participants will return to the clinic for visits at Week 1, Week 4, Week 12 and Week 26 and Week 52 Cohort B After randomization, participants will begin a 12-week schedule consisting of four-times-per-week treatment. Participants will return to the clinic for visits at Week 4 and Week 12. Safety and efficacy parameters will be recorded throughout the duration of the study.

Conditions

• Nonarteritic Anterior Ischemic Optic Neuropathy

Interventions

Type	Name	Description
DRUG	RPh201 Cohort A	RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
OTHER	Placebo Cohort A	The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).
DRUG	RPh201 Cohort B	RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
OTHER	Placebo Cohort B	The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene \[BHT\]).

Timeline

• Start date: 2018-07-10
• Primary completion: 2020-09-27
• Completion: 2020-09-27
• First posted: 2018-06-06
• Last updated: 2020-10-12

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study