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Clinical Trial Summary

This trial is a Phase 3 Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema. Stage 1 will confirm the safety and efficacy of OCS-01 versus Vehicle alone in subjects with diabetic macular edema (DME). Stage 2 will evaluate the efficacy and safety of OCS-01 in subjects with DME.


Clinical Trial Description

The trial outlined here is a randomized, double-masked, Vehicle-controlled clinical study of OCS-01 in the treatment of DME. The trial will consist of two stages: Stage 1: Subjects will be randomized 2:1 to receive OCS-01 in the study eye 6 times a day for the first 6 weeks then 3 times a day dosing (TID) for the remaining 6 weeks, or 6 times a day Vehicle dosing for 6 weeks followed by TID Vehicle dosing for 6 weeks. Stage 2: Subjects will be randomized 1:1 to receive the OCS-01 or Vehicle in the dosing regimen from Stage 1 in the study eye for the first 12 weeks (6 times a day for 6 weeks, TID for 6 weeks), then both arms will continue at TID dosing through the Week 52 Visit. No subjects from Stage 1 will be enrolled into Stage 2. All treatments will be self-administered in the study eye only. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05066997
Study type Interventional
Source Oculis
Contact David Jacobs
Phone (609) 613-8551
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date September 29, 2021
Completion date August 30, 2024

See also
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