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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

NCT ID: NCT05695417

Last Updated: 2023-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-15

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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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

Conditions

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Non-proliferative Diabetic Retinopathy

Keywords

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Nonproliferative diabetic retinopathy Diabetic retinopathy OTX-TKI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2:1
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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OTX-TKI

Group Type ACTIVE_COMPARATOR

OTX-TKI

Intervention Type DRUG

Injection of OTX-TKI

Sham

Group Type SHAM_COMPARATOR

Sham

Intervention Type DRUG

Sham Injection of OTX-TKI

Interventions

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OTX-TKI

Injection of OTX-TKI

Intervention Type DRUG

Sham

Sham Injection of OTX-TKI

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ocular Therapeutix, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ocular Therapeutix Inc

Phoenix, Arizona, United States

Site Status

Ocular Therapeutix, Inc.

Bakersfield, California, United States

Site Status

Ocular Therapeutix, Inc.

Augusta, Georgia, United States

Site Status

Ocular Therapeutix, Inc.

Lemont, Illinois, United States

Site Status

Ocular Therapeutix, Inc.

Hagerstown, Maryland, United States

Site Status

Ocular Therapeutix, Inc.

Reno, Nevada, United States

Site Status

Ocular Therapeutiux, Inc.

Austin, Texas, United States

Site Status

Ocular Therapeutix Inc

Bellaire, Texas, United States

Site Status

Ocular Therapeutix, Inc

San Antonio, Texas, United States

Site Status

Ocular Therapeutix Inc.

The Woodlands, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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OTX-TKI-2022-101

Identifier Type: -

Identifier Source: org_study_id