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

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NCT07235085 · readout ≤ 224 d

Sponsored by Ocular Therapeutix, Inc. (industry) · OCUL — their whole pipeline →.

Phase

Phase 3

Status

Recruiting

Study type

Interventional

Design

Randomized · Quadruple · Treatment

Enrollment

930estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2025-11-17

actual

When the study began enrolling

Primary completion

Mar 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Mar 2027

estimated

The whole study's end, after follow-up

First posted

2025-11-19

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-03-16

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

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

Primary outcome

what the primary-completion date above is the date OF

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)

measured 52 weeks

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