Nonarteritic Anterior Ischemic Optic Neuropathy Clinical Trial
Official title:
A Double-Masked Clinical Study Evaluating the Efficacy and Safety of RPh201 Treatment in Participants With Previous NAION
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.
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.
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