NCT06011798

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Unity Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Diabetic Macular Edema
• Retinal Disease
• Macular Edema
• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Degeneration
• Retinal Diseases
• Eye Diseases
• Edema

Interventions

Type	Name	Description
DRUG	Aflibercept	Anti-VEGF control
DRUG	foselutoclax	Experimental drug

Timeline

• Start date: 2023-08-23
• Primary completion: 2025-01-21
• Completion: 2025-04-08
• First posted: 2023-08-25
• Last updated: 2025-08-05
• Results posted: 2025-08-05

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study