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

Study Summary

The purpose of this trial is to study the safety and effectiveness of OTX-TKI (axitinib intravitreal hydrogel) for the treatment of Non-Proliferative Diabetic Retinopathy. OTX-TKI is an intravitreal hydrogel embedded with axitinib. When the OTX-TKI hydrogel is administered into the vitreous cavity of the eye, the hydrogel begins to slowly break down, which allows the axitinib to be slowly released over time. This clinical trial is comparing OTX-TKI to a "sham" injection procedure. The sham injection is a mock injection procedure, but nothing will actually be inserted in the eye as there is no needle on the sham injector. Only one eye ("study eye") will be treated with study treatment.

Conditions

Non-Proliferative Diabetic Retinopathy

Interventions / Drugs

Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24 Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24

View on ClinicalTrials.gov ↗

Sponsor

Study Details

Enrollment930 participants

Primary Completion—

Lead SponsorOcular Therapeutix, Inc.

Data Retrieved2026-04-11 04:23:15.556949+00:00

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