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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 52
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and Tolerability
Secondary outcome measures
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
53 Previous Clinical Trials
5,556 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor have any available enrollment slots?

"The information found on clinicaltrials.gov suggests that this research-based endeavour is presently enlisting trial subjects. This study was initially posted on the 15th of January, 2023 and its details were recently refreshed in mid-February."

Answered by AI

To what degree is OTX-TKI deleterious to individuals?

"Due to the limited clinical evidence, our team has assigned OTX-TKI a safety rating of 1 on the scale of 1 to 3. This indicates that it is currently in a Phase 1 trial and more data needs to be collected regarding its efficacy."

Answered by AI

How many participants have been recruited for this research endeavor?

"Affirmative. According to the clinicaltrials.gov, this research initiative which was announced on January 15th 2023 is presently recruiting participants. 21 individuals are required across two locations for completion of the study."

Answered by AI

Who else is applying?

What state do they live in?
Louisiana
What site did they apply to?
Ocular Therapeutix, Inc
Ocular Therapeutix, Inc.
Ocular Therapeutix Inc.
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have been to multiple doctors here in Louisiana with no help, i am determined to see again!
PatientReceived 1 prior treatment
~10 spots leftby Mar 2025