Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
Completed · Phase 2
Conditions studied: Diabetic Macular Edema, Retinal Disease, Macular Edema, Diabetes Mellitus, Diabetic Retinopathy, Retinal Degeneration, Retinal Diseases, Eye Diseases, Edema
In brief
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
Key facts
- Study ID
- NCT06011798
- Run by
- Unity Biotechnology, Inc.
- People needed
- 52
- Starts
- 2023-08-23
- Expected to finish
- 2025-04-08
- Last updated by the study team
- 2025-08-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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