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

Conditions

• Non-Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Single intravitreal injection of axitinib hydrogel implant followed by a mock (sham) injection procedure at Week 24 — DRUG
  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 — DRUG
  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 — OTHER
  sham/mock intravitreal injection procedure

Study Details

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.

Key Dates

Start date

Nov 17, 2025

Status verified

Mar 2026

Primary completion

Mar 31, 2027

Completion

Mar 31, 2027

Study Design

Enrollment

930 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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

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

• Clinical Project Manager
  7813574000
  [email protected]

Locations (1)

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