Actively Recruiting
A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy
Led by Ocular Therapeutix, Inc. · Updated on 2026-03-16
930
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- History of or newly diagnosed type 1 or type 2 diabetes mellitus
- Moderately severe to severe Non-Proliferative Diabetic Retinopathy (DRSS levels 47 or 53) confirmed by Central Reading Center
- Best corrected visual acuity (BCVA) of 69 letters or more on the ETDRS scale (about 20/40 vision or better) in the study eye
- Willing and able to comply with clinic visits and study procedures
- Signed informed consent form provided
You will not qualify if you...
- Presence of center-involved diabetic macular edema in the study eye as determined by optical coherence tomography at screening
- Rhegmatogenous retinal detachment or visually significant epiretinal membrane, vitreomacular traction syndrome, macular hole, retinal pigment epithelium tear in the macula, or other significant macular disease in the study eye
- Prior panretinal photocoagulation treatment in the study eye before baseline
- Focal or grid laser photocoagulation within 1000 microns of the central macula within 6 months before baseline
- Intravitreal anti-VEGF treatment in the study eye within 6 months before baseline or any prior port delivery system with ranibizumab in the study eye
- Additional exclusion criteria apply
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States, 21740
Actively Recruiting
Research Team
C
Clinical Project Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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