A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)

Other illness

• Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.

Other

• Have macular edema considered to be because of a cause other than DME.
• Have a decrease in BCVA because of causes other than DME.

• Have a signed informed consent form before any study-specific procedures are performed.
• Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
• Have a documented diagnosis of type 1 or type 2 diabetes mellitus at Visit 1 (Screening).
• Have a signed informed consent form before any study-specific procedures are performed.
• Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with central subfield thickness (CST) of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
• Have a documented diagnosis of type 1 or type 2 diabetes mellitus prior to Visit 1 (Screening).