OTX-TKI (axitinib intravitreal implant) for non-proliferative diabetic retinopathy
A Phase 3, Multicenter, Double-Masked, Randomized, 3-Arm Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTXTKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy
This trial will test whether a long-acting axitinib hydrogel implant injected into one eye can slow worsening in adults with moderately severe to severe non-proliferative diabetic retinopathy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 930 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ocular Therapeutix, Inc. Industry-sponsored |
| Drugs / interventions | ranibizumab, axitinib |
| Locations | 1 site (Hagerstown, Maryland) |
| Trial ID | NCT07235085 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with type 1 or 2 diabetes, moderately severe to severe NPDR (DRSS 47 or 53), good central vision (ETDRS ≥69) in the study eye, and no center-involved diabetic macular edema are ideal candidates.
Not a fit: Patients with center-involved diabetic macular edema, significant retinal disease such as retinal detachment or severe epiretinal membrane, or poor visual acuity in the study eye are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the implant could slow disease progression and reduce the need for frequent intravitreal injections by providing sustained drug delivery.
How similar studies have performed: Sustained-release anti-VEGF approaches have shown promise in diabetic eye disease, but the intravitreal axitinib hydrogel implant is a newer strategy with limited prior large-scale data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Hagerstown, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.