Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
- Conditions
- Retinal DegenerationEdemaDiabetic Macular EdemaMacular EdemaDiabetic RetinopathyEye DiseasesRetinal DiseaseDiabetes MellitusRetinal Diseases
- Interventions
- Registration Number
- NCT06011798
- Lead Sponsor
- Unity Biotechnology, Inc.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Anti-VEGF control arm Aflibercept 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. foselutoclax arm Aflibercept 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. foselutoclax arm foselutoclax 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.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter Week 24 Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
- Secondary Outcome Measures
Name Time Method Assess Safety Outcome - Safety and Tolerability 36 weeks Number of participants with treatment-emergent adverse event (TEAE)
Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36 36 weeks Changes in BCVA (ETDRS letters) from baseline to Week 36
Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36 36 weeks Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 36
Assess Other Efficacy Outcome - Rescue Metrics 36 weeks At any visit, including Unscheduled visits, patients who exhibited increase in disease activity, were allowed to be rescued with aflibercept. Increase in disease activity was defined as ANY of the following:
* Worsening CST by ≥75 µm from baseline per SD-OCT
* A ≥10 letter decrease in BCVA compared to baseline
* New clinically significant blood or heme present compared to previous visit
* PI discretion (rationale to be documented in the EDC)Ocular Safety and Tolerability 36 weeks Ocular Safety is evaluated by incidence of ocular Treatment Emergent Adverse Events (TEAEs).
Trial Locations
- Locations (19)
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
🇺🇸Saint Petersburg, Florida, United States
University Retina and Macula Associates
🇺🇸Lemont, Illinois, United States
Midwest Eye
🇺🇸Carmel, Indiana, United States
Scroll for more (9 remaining)California Retina Consultants🇺🇸Bakersfield, California, United States