NCT06011798CompletedPhase 2
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
A Phase 2b, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With Diabetic Macular Edema
Source: ClinicalTrials.gov · Last updated 5 Aug 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 52 (actual)
- First submitted
- 2 Aug 2023
- Start date
- 23 Aug 2023
- Primary completion date
- 21 Jan 2025
- Lead sponsor
- Unity Biotechnology, Inc.
- Diseases
- Diabetic eye disease
- NCT number
- NCT06011798
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 52
- From 23 Aug 2023 to the primary completion date, 21 Jan 2025
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any medical condition that is uncontrolled and may prevent participation in this study, as determined by the Investigator or disqualify individuals from enrollment.
Other
- Significant media opacities, including cataract, or posterior capsule opacification, which might interfere with VA, assessment of toxicity, or fundus imaging in either eye.
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina Research Institution of Texas Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Retina-Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Midwest Eye Coordinator of this site? Confirm its status | Carmel | United States | Unknown status |
| Rand Eye Institute Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Erie Retina Research LLC Coordinator of this site? Confirm its status | Erie | United States | Unknown status |
| Retina Consultants of Carolina Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Cumberland Valley Retina Consultants Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Salehi Retina Institute, Inc Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| University Retina and Macula Associates Coordinator of this site? Confirm its status | Lemont | United States | Unknown status |
| Advanced Vision Research Institute Coordinator of this site? Confirm its status | Longmont | United States | Unknown status |
| Florida Eye Associates Coordinator of this site? Confirm its status | Melbourne | United States | Unknown status |
| Vision Research Solutions PLLC Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Unknown status |
| Austin Retina Associates Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| Retina Center of Texas Coordinator of this site? Confirm its status | Southlake | United States | Unknown status |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Bay Area Retina Associates Coordinator of this site? Confirm its status | Walnut Creek | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.