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

Last updated: November 14, 2025
Sponsor: Ocular Therapeutix, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Diabetic Vitreous Hemorrhage

Diabetic Retinopathy

Treatment

Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24

Sham/mock procedure of intravitreal injection followed by a second sham/mock procedure at Week 24

Intravitreal injection of axitinib hydrogel implant followed by a second intravitreal injection of the axitinib implant at Week 24

Clinical Study ID

NCT07235085
OTX-TKI-2025-NPDR-302
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Male or female who is at least 18 years of age at the time of signing the informedconsent form (ICF)

  2. History of or newly diagnosed with type 1 or 2 diabetes mellitus and have moderatelysevere to severe NPDR (DRSS levels 47 or 53), confirmed by the Central ReadingCenter (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

Exclusion Criteria:

  1. Presence of center-involved diabetic macular edema (CI-DME) defined per protocol viaoptical coherence tomography (SD-OCT) in the study eye, obtained at the Screeningvisit

  2. Evidence of a rhegmatogenous retinal detachment or visually significant/severeepiretinal membrane, vitreomacular traction syndrome, macular hole, tear of theretinal pigment epithelium in the macula, or other macular pathology in the studyeye 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 centralsubfield 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)

Study Design

Total Participants: 930
Treatment Group(s): 3
Primary Treatment: Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24
Phase: 3
Study Start date:
November 17, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Cumberland Valley Retina Consultants

    Hagerstown 4357141, Maryland 4361885 21740
    United States

    Active - Recruiting

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