The primary objective of this study is to evaluate the efficacy and safety of the topical ophthalmic administration of OCS 01 as compared to Vehicle in participants with Diabetic Macular Edema (DME).
A Phase 3 Pivotal Double-masked, Randomized, Vehicle-controlled, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in participants with Diabetic Macular Edema
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
401
Participants will be dosed with one eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
Participants will be dosed with one eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase).
Mean Change from Baseline in BCVA (Best Corrected Visual Acuity)
Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the ETDRS chart representing better visual acuity.
Time frame: Week 52
Percentage of Participants With a 3-line or Greater Gain in BCVA
BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Time frame: Baseline, Week 52
Mean Change in BCVA
BCVA will be assessed using ETDRS letters score: higher numbers on the ETDRS chart representing better visual acuity.
Time frame: Baseline, Week 12 and Week 24
Mean Change in Central Subfield Thickness (CST)
CST will be measured by spectral domain optical coherence tomography (SD-OCT)
Time frame: Baseline, Week 52
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