Phase 2
Completed N=52
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
Source: ClinicalTrials.gov NCT06011798 ↗Enrolled (actual)
52
Serious AEs
9.6%
Results posted
Aug 2025
Primary outcomePrimary: Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter — 5.1; 3.7 change in ETDRS letters
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter |
5.1; 3.7 | — |
| SECONDARY Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36 |
4.7; 4.6 | — |
| SECONDARY Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36 |
9.2; -1.9 | — |
| SECONDARY Assess Other Efficacy Outcome - Rescue Metrics |
61.5; 34; 23.1; 34.6; 15.4; 30.8 | — |
| SECONDARY Assess Safety Outcome - Safety and Tolerability |
15; 22; 12; 19; 8; 8 | — |
| SECONDARY Ocular Safety and Tolerability |
12; 19; 8; 15; 8; 15 | — |
Eligibility Criteria
Inclusion Criteria
- 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)
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06011798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.