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

Ocular Therapeutix, Inc.21 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-proliferative Diabetic Retinopathy

Interventions

OTX-TKIDRUG

Injection of OTX-TKI

ShamDRUG

Sham Injection of OTX-TKI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

Ocular Therapeutix Inc

Phoenix, Arizona, United States

Ocular Therapeutix, Inc.

Bakersfield, California, United States

Ocular Therapeutix, Inc.

Augusta, Georgia, United States