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

Sponsor
Ocular Therapeutix, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05695417
Collaborator
(none)
21
Enrollment
2
Arms
12
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Anticipated Enrollment :
21 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
2:12:1
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: OTX-TKI

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

Drug: Sham
Sham Injection of OTX-TKI

Outcome Measures

Primary Outcome Measures

  1. Safety and Tolerability [Baseline up to Week 52]

    Frequency of treatment emergent adverse events

Secondary Outcome Measures

  1. Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score [Baseline up to Week 52]

    BCVA changes from baseline

  2. Central subfield thickness changes [Baseline up to Week 52]

    Central subfield thickness changes from baseline

  3. Rescue Therapy [Baseline up to Week 52]

    Proportion of subjects receiving rescue therapy

  4. Diabetic Retinopathy Severity Scale (DRSS) changes [Baseline up to Week 52]

    DRSS changes from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ocular Therapeutix, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ocular Therapeutix, Inc.
ClinicalTrials.gov Identifier:
NCT05695417
Other Study ID Numbers:
  • OTX-TKI-2022-101
First Posted:
Jan 25, 2023
Last Update Posted:
Jan 25, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ocular Therapeutix, Inc.
Nonproliferative diabetic retinopathy
Diabetic retinopathy OTX-TKI
Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy

Study Results

No Results Posted as of Jan 25, 2023