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

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

Detailed Description
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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

Official Title
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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

Conditions
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Non-proliferative Diabetic Retinopathy

Intervention / Treatment
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* Drug: OTX-TKI
* Drug: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 2:1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: OTX-TKI<br> | Drug: OTX-TKI<br>* Injection of OTX-TKI<br>|
| Sham Comparator: Sham<br> | Drug: Sham<br>* Sham Injection of OTX-TKI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability | Frequency of treatment emergent adverse events | Baseline up to Week 52 | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonproliferative diabetic retinopathy, Diabetic retinopathy OTX-TKI