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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

Primary Purpose

Non-proliferative Diabetic Retinopathy

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OTX-TKI
Sham
Sponsored by
Ocular Therapeutix, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-proliferative Diabetic Retinopathy focused on measuring Nonproliferative diabetic retinopathy, Diabetic retinopathy OTX-TKI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ocular Therapeutix IncRecruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutix, Inc.Recruiting
  • Ocular Therapeutiux, Inc.Recruiting
  • Ocular Therapeutix IncRecruiting
  • Ocular Therapeutix, IncRecruiting
  • Ocular Therapeutix Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

OTX-TKI

Sham

Arm Description

Outcomes

Primary Outcome Measures

Safety and Tolerability
Frequency of treatment emergent adverse events

Secondary Outcome Measures

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

Full Information

First Posted
January 5, 2023
Last Updated
June 12, 2023
Sponsor
Ocular Therapeutix, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05695417
Brief Title
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocular Therapeutix, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-proliferative Diabetic Retinopathy
Keywords
Nonproliferative diabetic retinopathy, Diabetic retinopathy OTX-TKI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
2:1
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
OTX-TKI
Arm Type
Active Comparator
Arm Title
Sham
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
OTX-TKI
Intervention Description
Injection of OTX-TKI
Intervention Type
Drug
Intervention Name(s)
Sham
Intervention Description
Sham Injection of OTX-TKI
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
Frequency of treatment emergent adverse events
Time Frame
Baseline up to Week 52
Secondary Outcome Measure Information:
Title
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Description
Best Corrected Visual Acuity (BCVA) changes from baseline
Time Frame
Baseline up to Week 52
Title
Central subfield thickness changes
Description
Central subfield thickness changes from baseline
Time Frame
Baseline up to Week 52
Title
Rescue Therapy
Description
Proportion of subjects receiving rescue therapy
Time Frame
Baseline up to Week 52
Title
Diabetic Retinopathy Severity Scale (DRSS) changes
Description
Diabetic Retinopathy Severity Scale (DRSS) changes from baseline
Time Frame
Baseline up to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Project Manager
Phone
1-781-357-4000
Email
clinicalaffairs@ocutx.com
Facility Information:
Facility Name
Ocular Therapeutix Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Bakersfield
State/Province
California
ZIP/Postal Code
93308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Lemont
State/Province
Illinois
ZIP/Postal Code
60439
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc.
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutiux, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78750
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix Inc
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager
Facility Name
Ocular Therapeutix Inc.
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Project Manager

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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