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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 belowSelect...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 52
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 moreTrial 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.The center of your eye is thicker than 320 micrometers.My eye condition has worsened in the past 6 months, affecting my central vision.I have swelling near the center of my retina.My eye condition is classified as moderately severe to severe non-proliferative diabetic retinopathy.I have diabetes.Your vision in the study eye is at least 20/40 or better.
Research Study Groups:
This trial has the following groups:- Group 1: OTX-TKI
- Group 2: Sham
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT05695417 — Phase 1