Clinical trial NCT05695417: Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-TKI in Subjects With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Non-proliferative Diabetic Retinopathy
Keywords: Nonproliferative diabetic retinopathy
Diabetic retinopathy OTX-TKI
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2:1
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Safety and Tolerability
timeFrame: Baseline up to Week 52
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score
timeFrame: Baseline up to Week 52
measure: Central subfield thickness changes
timeFrame: Baseline up to Week 52
measure: Rescue Therapy
timeFrame: Baseline up to Week 52
measure: Diabetic Retinopathy Severity Scale (DRSS) changes
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Ocular Therapeutix Inc
state: Arizona
city: Bakersfield
country: United States
facility: Ocular Therapeutix, Inc.
state: California
city: Augusta
country: United States
facility: Ocular Therapeutix, Inc.
state: Georgia
city: Lemont
country: United States
facility: Ocular Therapeutix, Inc.
state: Illinois
city: Hagerstown
country: United States
facility: Ocular Therapeutix, Inc.
state: Maryland
city: Reno
country: United States
facility: Ocular Therapeutix, Inc.
state: Nevada
city: Austin
country: United States
facility: Ocular Therapeutiux, Inc.
state: Texas
city: Bellaire
country: United States
facility: Ocular Therapeutix Inc
state: Texas
city: San Antonio
country: United States
facility: Ocular Therapeutix, Inc
state: Texas
city: The Woodlands
country: United States
facility: Ocular Therapeutix Inc.
state: Texas
Study officials:
References: