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Tyrosine Kinase Inhibitor

OTX-TKI for Diabetic Retinopathy

Phase 1
Waitlist Available
Research Sponsored by Ocular Therapeutix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Presence of DME threatening the center (within 200 microns) of the macula in the study eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 52

Summary

This trial will test a new drug to treat non-proliferative diabetic retinopathy, looking at its safety, tolerability, and effectiveness.

Who is the study for?
This trial is for adults with moderately severe to severe non-proliferative diabetic retinopathy (NPDR), which is a condition affecting the retina due to diabetes. Participants must have certain levels of NPDR severity, type 1 or type 2 diabetes, and good vision in the study eye. People with recent macular edema or swelling threatening the central vision area cannot join.
What is being tested?
The trial tests OTX-TKI's safety and effectiveness compared to a sham treatment for NPDR. OTX-TKI is an investigational drug that could potentially help prevent worsening of this retinal disease.
What are the potential side effects?
While specific side effects are not listed here, common ones related to eye treatments may include discomfort at the injection site, redness, blurred vision, floaters, increased pressure inside the eye, and possible infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
Select...
My eye condition is classified as moderately severe to severe non-proliferative diabetic retinopathy.
Select...
I have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have swelling near the center of my retina.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Tolerability
Secondary study objectives
Central subfield thickness changes
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
Diabetic Retinopathy Severity Scale (DRSS) changes
+1 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: OTX-TKIActive Control1 Intervention
Group II: ShamPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Lead Sponsor
54 Previous Clinical Trials
6,381 Total Patients Enrolled

Media Library

OTX-TKI (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05695417 — Phase 1
Diabetic Retinopathy Research Study Groups: OTX-TKI, Sham
Diabetic Retinopathy Clinical Trial 2023: OTX-TKI Highlights & Side Effects. Trial Name: NCT05695417 — Phase 1
OTX-TKI (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695417 — Phase 1
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05695417 — Phase 1
~7 spots leftby Nov 2025
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