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

December 7, 2023 updated by: Ocular Therapeutix, Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Ocular Therapeutix Inc
    • California
      • Bakersfield, California, United States, 93308
        • Ocular Therapeutix, Inc.
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Ocular Therapeutix, Inc.
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Ocular Therapeutix, Inc.
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Ocular Therapeutix, Inc.
    • Nevada
      • Reno, Nevada, United States, 89502
        • Ocular Therapeutix, Inc.
    • Texas
      • Austin, Texas, United States, 78750
        • Ocular Therapeutiux, Inc.
      • Bellaire, Texas, United States, 77401
        • Ocular Therapeutix Inc
      • San Antonio, Texas, United States, 78211
        • Ocular Therapeutix, Inc
      • The Woodlands, Texas, United States, 77384
        • Ocular Therapeutix Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham
Drug: Sham
Sham Injection of OTX-TKI
Active Comparator: OTX-TKI
Drug: OTX-TKI
Injection of OTX-TKI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: Baseline up to Week 52
Frequency of treatment emergent adverse events
Baseline up to Week 52

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ocular Therapeutix, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2023

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 5, 2023

First Submitted That Met QC Criteria

January 12, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OTX-TKI-2022-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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