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NCT05695417 Clinical Trial

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

Non-proliferative Diabetic Retinopathy Clinical Trial

Official title:
A Phase 1B, 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05695417
Other study ID # OTX-TKI-2022-101
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date January 15, 2023
Est. completion date December 2024

Study information
Verified date December 2023
Source Ocular Therapeutix, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 21
Est. completion date December 2024
Est. primary completion date January 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• OTX-TKI
Injection of OTX-TKI
• Sham
Sham Injection of OTX-TKI

Locations
Country Name City State
United States Ocular Therapeutix, Inc. Augusta Georgia
United States Ocular Therapeutiux, Inc. Austin Texas
United States Ocular Therapeutix, Inc. Bakersfield California
United States Ocular Therapeutix Inc Bellaire Texas
United States Ocular Therapeutix, Inc. Hagerstown Maryland
United States Ocular Therapeutix, Inc. Lemont Illinois
United States Ocular Therapeutix Inc Phoenix Arizona
United States Ocular Therapeutix, Inc. Reno Nevada
United States Ocular Therapeutix, Inc San Antonio Texas
United States Ocular Therapeutix Inc. The Woodlands Texas

Sponsors (1)
Lead Sponsor Collaborator
Ocular Therapeutix, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety and Tolerability Frequency of treatment emergent adverse events Baseline up to Week 52
Secondary Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score Best Corrected Visual Acuity (BCVA) changes from baseline Baseline up to Week 52
Secondary Central subfield thickness changes Central subfield thickness changes from baseline Baseline up to Week 52
Secondary Rescue Therapy Proportion of subjects receiving rescue therapy Baseline up to Week 52
Secondary Diabetic Retinopathy Severity Scale (DRSS) changes Diabetic Retinopathy Severity Scale (DRSS) changes from baseline Baseline up to Week 52
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