Overview
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
Not yet recruiting
Trial end date:
2024-01-01
2024-01-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic RetinopathyPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
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