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.
- Primary Outcome Measures
Name Time Method Mean change from baseline in BCVA by ETDRS letter 24 weeks Mean change from baseline in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
- Secondary Outcome Measures
Name Time Method Assess other efficacy outcome - Rescue metrics 24 and 36 weeks Proportion of participants who do not require rescue
Assess other efficacy outcome - Changes in BCVA 24 and 36 weeks Changes in BCVA from baseline to last observation at or prior to Week 36
Assess safety outcome - TEAE 24 and 36 weeks Percentage of participants with at least one treatment-emergent ocular adverse event (AE) in the SE or Fellow Eye (FE)
Assess other efficacy outcome - ETDRS gains 24 and 36 weeks Proportion of participants gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline in the Study Eye (SE) to Week 36
Assess other efficacy outcome - Changes in CST 24 and 36 weeks Change in Central Subfield Thickness (CST) as measured in microns from baseline to each visit through Week 36
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
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Midwest Eye
🇺🇸Carmel, Indiana, United States
Sierra Eye Associates
🇺🇸Reno, Nevada, United States
EyeHealth Northwest
🇺🇸Portland, Oregon, United States
Erie Retina Research, LLC
🇺🇸Erie, Pennsylvania, United States
Retina Consultants of Carolina
🇺🇸Greenville, South Carolina, United States
Vision Research Solutions, PLLC
🇺🇸Philadelphia, Pennsylvania, 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