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

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ocular Therapeutix, Inc.

Criteria

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