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NCT07235085 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy
A Phase 3 study of Non-Proliferative Diabetic Retinopathy, sponsored by Ocular Therapeutix.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 930
- Enrollment target
- 1
- Study location
NCT07235085: Recruiting Phase 3 study of Non-Proliferative Diabetic Retinopathy, sponsored by Ocular Therapeutix.
NCT07235085 is a Phase 3 study of Non-Proliferative Diabetic Retinopathy that is actively recruiting participants, run by Ocular Therapeutix. The registered enrollment target is 930 participants, above the 117-participant average among 4 other Non-Proliferative Diabetic Retinopathy trials with a reported enrollment target (695% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07235085, a Phase 3 study of Non-Proliferative Diabetic Retinopathy, is actively recruiting participants, sponsored by Ocular Therapeutix.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 930 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The Diabetic Retinopathy Severity Scale (DRSS) measures the severity of the diabetic retinopathy in patients by grading retinal images obtained by color fundus photography. Severity is determined by the presence of specific signs.
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 |
What NCT07235085 shows while recruiting
NCT07235085 is an interventional study that assigns participants to a tested intervention. The registered 930 participants enrollment target is mid-sized for trials with a published cap, above the 117-participant average among 4 other Non-Proliferative Diabetic Retinopathy trials with a reported enrollment target (695% higher).
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.
NCT07235085 reports a single indexed study location in Maryland.
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.
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).
Who is sponsoring clinical trial NCT07235085?
This trial is sponsored by Ocular Therapeutix, which has 20 total clinical trials registered on ClinicalTrials.gov.
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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