NCT05695417

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2023

Completed
10 days until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

12 months

First QC Date

January 5, 2023

Last Update Submit

December 7, 2023

Conditions

Non-proliferative Diabetic Retinopathy

Keywords

Nonproliferative diabetic retinopathyDiabetic retinopathy OTX-TKI

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Frequency of treatment emergent adverse events

    Baseline up to Week 52

Secondary Outcomes (4)

  • Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score

    Baseline up to Week 52

  • Central subfield thickness changes

    Baseline up to Week 52

  • Rescue Therapy

    Baseline up to Week 52

  • Diabetic Retinopathy Severity Scale (DRSS) changes

    Baseline up to Week 52

Study Arms (2)

OTX-TKI

ACTIVE COMPARATOR
Drug: OTX-TKI

Sham

SHAM COMPARATOR
Drug: Sham

Interventions

OTX-TKIDRUG

Injection of OTX-TKI

OTX-TKI
ShamDRUG

Sham Injection of OTX-TKI

Sham

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ocular Therapeutix Inc

Phoenix, Arizona, 85053, United States

Location

Ocular Therapeutix, Inc.

Bakersfield, California, 93308, United States

Location

Ocular Therapeutix, Inc.

Augusta, Georgia, 30909, United States

Location

Ocular Therapeutix, Inc.

Lemont, Illinois, 60439, United States

Location

Ocular Therapeutix, Inc.

Hagerstown, Maryland, 21740, United States

Location

Ocular Therapeutix, Inc.

Reno, Nevada, 89502, United States

Location

Ocular Therapeutiux, Inc.

Austin, Texas, 78750, United States

Location

Ocular Therapeutix Inc

Bellaire, Texas, 77401, United States

Location

Ocular Therapeutix, Inc

San Antonio, Texas, 78211, United States

Location

Ocular Therapeutix Inc.

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Interventions

salicylhydroxamic acid

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2:1
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

January 25, 2023

Study Start

January 15, 2023

Primary Completion

January 1, 2024

Study Completion

December 1, 2024

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

US(10)