# A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy

> **NCT07235085** · PHASE3 · RECRUITING · sponsor: **Ocular Therapeutix, Inc.** · enrollment: 930 (estimated)

## Conditions studied

- Non-Proliferative Diabetic Retinopathy

## 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

## Key facts

- **NCT ID:** NCT07235085
- **Lead sponsor:** Ocular Therapeutix, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-11-17
- **Primary completion:** 2027-03
- **Final completion:** 2027-03
- **Target enrollment:** 930 (ESTIMATED)
- **Last updated:** 2026-03-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07235085

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07235085, "A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT07235085. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*