NCT04762017

OCS-05 in Patients With Optic Neuritis

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of OCS-05 in Patients With Acute Optic Neuritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Oculis · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and tolerability of OCS-05 compared to placebo in patients with optic neuritis receiving the standard of care

Detailed description

ACUITY is a phase 2, multicentric, two-arm, randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of OCS-05 compared to placebo in patients with acute optic neuritis (AON) receiving the standard of care. Patients received OCS-05 2mg/kg/day, 3mg/kg/day or placebo for five days in addition corticosteroid standard of care (SoC).

Conditions

• Optic Neuritis

Interventions

Type	Name	Description
DRUG	OCS-05 +SoC (corticosteroid) IV administration	OCS-05 + SoC (corticosteroid) IV administration for 5 consecutive days
OTHER	Placebo + SoC (corticosteroid) IV administration	Placebo + SoC (corticosteroid) IV administration for 5 consecutive days

Timeline

• Start date: 2021-02-10
• Primary completion: 2024-09-16
• Completion: 2024-09-16
• First posted: 2021-02-21
• Last updated: 2025-09-22

Locations

4 sites across 1 country: France