Randomized Controlled Phase 2a Study of RPh201 in Previous Nonarteritic Anterior Ischemic Optic Neuropathy.

ABSTRACT:

Background

No proven treatment exists for nonarteritic anterior ischemic optic neuropathy (NAION), either in the acute or late phase.

Objective

To assess safety and changes in visual function and structure after RPh201/placebo treatment in participants with previous NAION.

Design and setting

Phase 2a, single-site, prospective, randomized, placebo-controlled, double-masked trial (registration NCT02045212).

Main outcomes measures

Early Treatment Diabetic Retinopathy Study best-corrected visual acuity (BCVA), visual fields, retinal nerve fiber layer, and visual evoked potential at weeks 13, 26, and after a 13-week wash-out ("off-drug") period; and safety.

Study population

Twenty-two participants aged 18 years or older with previous NAION.

Intervention(s)

SUBMITTER: Rath EZ 

PROVIDER: S-EPMC6705418 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature