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

Phase 1

Active, not recruiting

• Conditions: Non-proliferative Diabetic Retinopathy
• Interventions: Drug: OTX-TKI; Drug: Sham

• Registration Number: NCT05695417
• Lead Sponsor: Ocular Therapeutix, Inc.

Brief Summary

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

Detailed Description

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 Timeline

• Study First Submitted: 2023-01-05
• Study First Submitted QC: 2023-01-12
• Study Start: 2023-01-15
• Study First Posted: 2023-01-25
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08
• Primary Completion: 2024-01
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OTX-TKI	OTX-TKI	-
Sham	Sham	-

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability	Baseline up to Week 52	Frequency of treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Rescue Therapy	Baseline up to Week 52	Proportion of subjects receiving rescue therapy
Central subfield thickness changes	Baseline up to Week 52	Central subfield thickness changes from baseline
Diabetic Retinopathy Severity Scale (DRSS) changes	Baseline up to Week 52	Diabetic Retinopathy Severity Scale (DRSS) changes from baseline
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score	Baseline up to Week 52	Best Corrected Visual Acuity (BCVA) changes from baseline

Trial Locations

Locations (5)

Ocular Therapeutix Inc; 🇺🇸 Bellaire, Texas, United States

Ocular Therapeutiux, Inc.; 🇺🇸 Austin, Texas, United States

Ocular Therapeutix, Inc; 🇺🇸 San Antonio, Texas, United States

Ocular Therapeutix Inc.; 🇺🇸 The Woodlands, Texas, United States

Ocular Therapeutix, Inc.; 🇺🇸 Reno, Nevada, United States