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NCT05695417
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Conditions: Non-proliferative Diabetic Retinopathy
Sex: All
Ages: 18 Years – N/A
Phase: PHASE1
Enrollment: 21
Sponsor: Ocular Therapeutix, Inc.
Summary
Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Eligibility Criteria
Inclusion Criteria:Are at least 18 years of age or olderModerately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading centerDiabetes type 1 or 2BCVA 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 eyePresence of DME threatening the center (within 200 microns) of the macula in the study eyeOCT CSFT of ≥320 μm in the study eye
Source: ClinicalTrials.gov (NCT05695417). StuddyBuddy aggregates publicly available trial information.
