Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

A Phase 1B, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (Axitinib Implant) for Intravitreal Injection in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05695417

Enrollment

Registered

2023-01-25

Start date

2023-01-15

Completion date

2024-12-31

Last updated

2023-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-proliferative Diabetic Retinopathy

Keywords

Nonproliferative diabetic retinopathy, Diabetic retinopathy OTX-TKI

Brief summary

Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Detailed description

Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI (axitinib implant) for Intravitreal Injection in Subjects with Moderately Severe to Severe Non-proliferative Diabetic Retinopathy

Interventions

DRUGOTX-TKI

Injection of OTX-TKI

DRUGSham

Sham Injection of OTX-TKI

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

2:1

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Are at least 18 years of age or older * Moderately severe to severe NPDR in the study eye defined as: DRSS levels of 47 or 53 as determined by the reading center * Diabetes type 1 or 2 * BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Exclusion criteria

* DME within 6 months involving the center of the macula in the study eye * Presence of DME threatening the center (within 200 microns) of the macula in the study eye * OCT CSFT of ≥320 μm in the study eye

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	Baseline up to Week 52	Frequency of treatment emergent adverse events

Secondary

Measure	Time frame	Description
Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score	Baseline up to Week 52	Best Corrected Visual Acuity (BCVA) changes from baseline
Central subfield thickness changes	Baseline up to Week 52	Central subfield thickness changes from baseline
Rescue Therapy	Baseline up to Week 52	Proportion of subjects receiving rescue therapy
Diabetic Retinopathy Severity Scale (DRSS) changes	Baseline up to Week 52	Diabetic Retinopathy Severity Scale (DRSS) changes from baseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026