Status:
COMPLETED
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
Lead Sponsor:
Unity Biotechnology, Inc.
Conditions:
Diabetic Macular Edema
Retinal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ar...
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) injecti...
Eligibility Criteria
Inclusion
- Patients aged ≥18 years.
- Patients with nonproliferative DR and DME
- Center-involved DME with Central Subfield Thickness (CST) ≥325-900 μm
- BCVA in the SE (most affected) of 70 to 30 ETDRS letters (equivalent to 20/40 to 20/250 on the Snellen chart)
Exclusion
- Concurrent disease in the study eye (SE) or structural damage, other than DME, that could compromise BCVA, prevent BCVA improvement, require medical or surgical intervention during the study period, confound interpretation of the results, or interfere with assessment of toxicity or Color Fundus Photography (CFP) in the SE.
- Significant media opacities, including cataract, or posterior capsule opacification, which might interfere with VA, assessment of toxicity, or fundus imaging in either eye.
- Any medical condition that is uncontrolled and may prevent participation in this study, as determined by the Investigator or disqualify individuals from enrollment.
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2025
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06011798
Start Date
August 23 2023
End Date
April 8 2025
Last Update
August 5 2025
Active Locations (19)
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1
California Retina Consultants
Bakersfield, California, United States, 93309
2
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
3
Salehi Retina Institute Inc.
Huntington Beach, California, United States, 92647
4
Bay Area Retina Associates
Walnut Creek, California, United States, 94598