OTX-TKI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized interventional trial compares a single intravitreal axitinib hydrogel implant to a sham procedure, with a second injection or sham at Week 24. The hydrogel slowly breaks down in the vitreous, releasing axitinib over time to provide sustained anti-VEGF activity. Only one eye (the study eye) is treated per participant and safety and effectiveness are monitored through scheduled clinic visits and imaging. The trial enrolls adults with moderately severe to severe NPDR without center-involved macular edema.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Male or female who is at least 18 years of age at the time of signing the informed consent form (ICF)
2. History of or newly diagnosed with type 1 or 2 diabetes mellitus and have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the Central Reading Center (CRC) based on the images obtained at the Screening visit
3. BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of ≥ 69 letters (approximate Snellen equivalent of 20/40 or better) in the study eye
4. Willing and able to comply with clinic visits and study-related procedures
5. Provide signed informed consent

Exclusion Criteria:

1. Presence of center-involved diabetic macular edema (CI-DME) defined per protocol via optical coherence tomography (SD-OCT) in the study eye, obtained at the Screening visit
2. Evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, vitreomacular traction syndrome, macular hole, tear of the retinal pigment epithelium in the macula, or other macular pathology in the study eye deemed visually significant by the Investigator
3. In the study eye, any panretinal photocoagulation (PRP) treatment prior to baseline, or received focal or grid laser photocoagulation within 1000 microns of the central subfield of the macula within 6 months prior to baseline
4. IVT anti-VEGF treatment in the study eye within 6 months or port delivery system (PDS) with ranibizumab in the study eye at any time prior to baseline (Day 1)
5. (There are additional exclusion criteria)

Where it's running

• Cumberland Valley Retina Consultants
  Hagerstown, Maryland, United States Recruiting

Study contacts

• Principal investigator: Allen Hu, MD — Cumberland Valley Retina Consultants
• Study coordinator: Clinical Project Manager
• Email: clinicalaffairs@ocutx.com
• Phone: 7813574000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.