Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
NCT ID: NCT06011798
Last Updated: 2025-08-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2023-08-23
2025-04-08
Brief Summary
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* Assess the efficacy of foselutoclax compared to aflibercept
* Assess the safety and tolerability of foselutoclax
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Anti-VEGF control arm
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 2 mg aflibercept (50 μl of 40 μg/μl solution) IVT on Day 1, Weeks 8, and 16. A sham procedure will also be administered on Day 1.
Aflibercept
Anti-VEGF control
foselutoclax arm
Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. Upon randomization, participants will receive 10 μg foselutoclax (50 μl of 0.2 μg/μl solution) IVT on Day 1 and Weeks 8 and 16. 2 mg aflibercept (50 μl of 40 μg/μl solution) will also be administered on Day 1.
Aflibercept
Anti-VEGF control
foselutoclax
Experimental drug
Interventions
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Aflibercept
Anti-VEGF control
foselutoclax
Experimental drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Unity Biotechnology, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Bhisitkul, MD, Ph.D.
Role: STUDY_DIRECTOR
Unity Biotechnology, Inc.
Locations
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California Retina Consultants
Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Salehi Retina Institute Inc.
Huntington Beach, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Advanced Vision Research Institute
Longmont, Colorado, United States
Rand Eye Institute
Deerfield Beach, Florida, United States
Florida Eye Associates
Melbourne, Florida, United States
Retina Vitreous Associates of Florida
St. Petersburg, Florida, United States
University Retina and Macula Associates
Lemont, Illinois, United States
Midwest Eye
Carmel, Indiana, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
Sierra Eye Associates
Reno, Nevada, United States
EyeHealth Northwest
Portland, Oregon, United States
Erie Retina Research, LLC
Erie, Pennsylvania, United States
Vision Research Solutions, PLLC
Philadelphia, Pennsylvania, United States
Retina Consultants of Carolina
Greenville, South Carolina, United States
Retina Research Institution of Texas
Abilene, Texas, United States
Austin Retina Associates
Round Rock, Texas, United States
Retina Center of Texas
Southlake, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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UBX1325-04
Identifier Type: -
Identifier Source: org_study_id
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