Recruiting PHASE3 INTERVENTIONAL 3-arm
NCT07235085
A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy (HELIOS-3)
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
Sponsor: Ocular Therapeutix, Inc.
Conditions
Non-Proliferative Diabetic Retinopathy
Interventions
Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24 Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24 Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24
Updated 1 time since 2025 Last updated: Nov 14, 2025 Started: Nov 17, 2025 Primary completion: Mar 31, 2027 Completion: Mar 31, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.
This PHASE3 trial investigates Non-Proliferative Diabetic Retinopathy and is currently actively recruiting participants. Ocular Therapeutix, Inc. leads this study, which shows 1 recorded version since 2025 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
1 version recorded Recruiting — PHASE3
[monthly]
Eligibility Summary
No eligibility information available.
Contact Information
Sponsor contact:
- Ocular Therapeutix, Inc.
Data source: Ocular Therapeutix, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .