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Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)

Diabetes Mellitus Clinical Trial

Official title:
A Phase 2b, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With Diabetic Macular Edema

Clinical Trial Summary

The goal of this clinical trial is to assess the efficacy and safety of multiple doses of foselutoclax (UBX1325) in patients with Diabetic Macular Edema. The main questions the study aims to answer are: - Assess the efficacy of foselutoclax compared to aflibercept - Assess the safety and tolerability of foselutoclax

Clinical Trial Description

This study is intended to assess the efficacy and safety of foselutoclax, a phosphate pro-drug, and its active parent molecule (UBX0601, a BCL-xL inhibitor) following repeat intravitreal (IVT) injections of foselutoclax in patients with Diabetic Macular Edema (DME). Approximately 50 patients will be enrolled and randomized 1:1 into either the foselutoclax arm,10 μg given 8 weeks apart, or the control arm of aflibercept, 2 mg every 8 weeks in order to assess the primary objective. All patients will be followed for approximately 36 weeks. The injector will be unmasked but the evaluator will remain masked throughout the study. This study will enroll participants ≥18 years of age with active DME disease despite treatment, with best corrected visual acuity (BCVA) between 70 to 30 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (equivalent to 20/40 to 20/250 on the Snellen chart). Once patients meet inclusion/exclusion criteria, patients will receive 3 run-in injections of aflibercept approximately 4 weeks apart, with the last aflibercept injection 4-6 weeks prior to Day 1. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06011798
Study type Interventional
Source Unity Biotechnology, Inc.
Contact Sharon Klier, MD, MPH
Phone 650-513-0096
Email UBX1325_medicalmonitor@unitybiotechnology.com
Status Recruiting
Phase Phase 2
Start date August 23, 2023
Completion date June 2025
View Details
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