Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

A Phase 1B, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Injection in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Inclusion Criteria:

• Are at least 18 years of age or older
• Moderately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading center
• Diabetes type 1 or 2
• BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Exclusion Criteria:

• DME within 6 months involving the center of the macula in the study eye
• Presence of DME threatening the center (within 200 microns) of the macula in the study eye
• OCT CSFT of ≥320 μm in the study eye