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

Ocular Therapeutix

Status and phase: Active, not recruiting; Phase 1

Conditions: Non-proliferative Diabetic Retinopathy

Treatments: Drug: OTX-TKI; Drug: Sham

Study type: Interventional

Funder types: Industry

Identifiers

NCT05695417

OTX-TKI-2022-101

Details and patient eligibility

About

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

Full 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

Enrollment: 21 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

21 participants in 2 patient groups

OTX-TKI

Active Comparator group

Treatment:

Drug: OTX-TKI

Sham

Sham Comparator group

Treatment:

Drug: Sham