OTX-TKI for Diabetic Retinopathy

Recruiting in Palo Alto (17 mi)

+9 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ocular Therapeutix, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.

My eye condition is classified as moderately severe to severe non-proliferative diabetic retinopathy.

I have diabetes.

+1 more

Exclusion Criteria

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.

Participant Groups

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.

2Treatment groups

Active Control

Placebo Group

Group I: OTX-TKIActive Control1 Intervention

Group II: ShamPlacebo Group1 Intervention