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A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy
NCT07235085 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DRUG Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24
- DRUG Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24
- OTHER Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24
Study Locations (1)
Maryland
- Cumberland Valley Retina Consultants — Hagerstown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 930 participants |
| Start Date | 2025-11-17 |
| Est. Completion | 2027-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07235085
The ClinicalTrials.gov registry entry for NCT07235085 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 930 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ocular Therapeutix, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Non-Proliferative Diabetic Retinopathy appearing as the primary indexed condition, and to 3 interventions — of which Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07235085 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07235085 about?
NCT07235085 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy". 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 ...
What is the current status of trial NCT07235085?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 930 participants. The study started on 2025-11-17. Estimated completion is 2027-03.
What conditions does trial NCT07235085 study?
This clinical trial studies the following conditions: Non-Proliferative Diabetic Retinopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07235085?
The interventions under investigation include: Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 (DRUG), Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24 (DRUG), Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24 (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07235085?
This trial is sponsored by Ocular Therapeutix, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07235085 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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