Recruiting
Phase 3

OTX-TKI

Sponsor:

Ocular Therapeutix, Inc.

Code:

NCT07235085

Conditions

Non-Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

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

Study Details

Brief 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

Non-Proliferative Diabetic Retinopathy

Study ID

NCT07235085

Start date

Nov 17, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Male or female who is at least 18 years of age at the time of signing the informed consent form (ICF)
2. History of or newly diagnosed with type 1 or 2 diabetes mellitus and have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the Central Reading Center (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 Criteria:

1. Presence of center-involved diabetic macular edema (CI-DME) defined per protocol via optical coherence tomography (SD-OCT) in the study eye, obtained at the Screening visit
2. Evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, vitreomacular traction syndrome, macular hole, tear of the retinal pigment epithelium in the macula, or other macular pathology in the study eye 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 central subfield 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

Enrollment

930 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: OTX-TKI Q52W (single dose)

OTX-TKI 0.45 mg via intravitreal (IVT) administration at Day 1 and sham procedure at Week 24

experimental: OTX-TKI Q24W (2 doses)

OTX-TKI 0.45 mg via IVT administration at Day 1 and Week 24

sham comparator: Sham Q24W (control)

Sham procedure at Day 1 and Week 24

Interventions

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

OTX-TKI 0.45 mg is a dried polyethylene glycol (PEG)-based hydrogel containing dispersed drug particles of the small molecule axitinib, a tyrosine kinase inhibitor (TKI).

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

OTX-TKI 0.45 mg is a dried polyethylene glycol (PEG)-based hydrogel containing dispersed drug particles of the small molecule axitinib, a tyrosine kinase inhibitor (TKI).

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

sham/mock intravitreal injection procedure

Primary outcome measure

  • DRSS 2-step change status at Week 52 from baseline in the study eye (≥ 2 step improvement, ≥ 2-step worsening, < 2-step change in either direction) [ Time Frame: 52 weeks ]

Central Contacts and Locations

Central contacts

Clinical Project Manager

7813574000clinicalaffairs@ocutx.com

Locations

Cumberland Valley Retina Consultants

Recruiting

Hagerstown, Maryland, United States, 21740

Contacts

Allen Hu, MD

7813574000clinicalaffairs@ocutx.com

More Information

Sponsor

Ocular Therapeutix, Inc.

Last update posted

Mar 16, 2026

Last verified

Mar, 2026

Keywords

  • Non-Proliferative Diabetic Retinopathy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ocular Therapeutix, Inc. on 2026-03-16.