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A Study of OTX-TKI for Non-Proliferative Diabetic Retinopathy

This study is looking into the safety and effectiveness of OTX-TKI (axitinib implant) for people with Non-Proliferative Diabetic Retinopathy (NPDR), a common eye condition in diabetes. OTX-TKI is a special implant that slowly releases axitinib, a medication that targets a specific protein (VEGF) involved in eye disease. You would receive either the OTX-TKI implant or a sham (mock) injection procedure in one eye. The study aims to see if OTX-TKI can improve your eye condition, specifically by looking for a 2-step change in your Diabetic Retinopathy Severity Scale (DRSS) score after 52 weeks. To join, you must be at least 18 years old and have moderately severe to severe NPDR.

Study design
This is an interventional study planning to enroll 930 participants. It compares OTX-TKI to a sham injection procedure.
What's involved
You would receive an intravitreal injection of OTX-TKI or a sham procedure, potentially followed by a second injection or sham procedure at Week 24.
Compensation
Not stated in the trial record.
Follow-up
Your eye condition will be measured at 52 weeks to assess the effectiveness of the treatment.

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NCT07235085

A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy

Recruiting
PHASE3Ages 18+InterventionalTreatment
Ocular Therapeutix, Inc.
~930 participants
Updated 2026-03-16 on ClinicalTrials.gov
What's tested:Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
DRSS 2-step change status at Week 52 from baseline in the study eye (≥ 2 step improvement, ≥ 2-step worsening, < 2-step change in either direction)
Measured over 52 weeks

Conditions

Non-Proliferative Diabetic Retinopathy

Explore related trials

Non-Proliferative Diabetic Retinopathy

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Allen Hu, MD · PRINCIPAL_INVESTIGATOR · Cumberland Valley Retina Consultants

Who to contact

Clinical Project Manager
[email protected]
7813574000
Email the study team

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What this trial measures

  • DRSS 2-step change status at Week 52 from baseline in the study eye (≥ 2 step improvement, ≥ 2-step worsening, < 2-step change in either direction)52 weeks

    The Diabetic Retinopathy Severity Scale (DRSS) measures the severity of the diabetic retinopathy in patients by grading retinal images obtained by color fundus photography. Severity is determined by the presence of specific signs.