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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-VEGF control arm | Active Comparator | 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 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept | Drug | Anti-VEGF control |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter | 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 | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36 | Changes in BCVA (ETDRS letters) from baseline to Week 36 | 36 weeks |
| Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Bhisitkul, MD, Ph.D. | Unity Biotechnology, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Retina Consultants | Bakersfield | California | 93309 | United States | ||
| Retina-Vitreous Associates Medical Group |
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| ID | Title | Description |
|---|---|---|
| FG000 | Anti-VEGF Control Arm | 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. Aflibercept: Anti-VEGF control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 26, 2024 | Jun 13, 2025 |
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| foselutoclax |
| Drug |
Experimental drug |
|
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Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 36
| 36 weeks |
| Assess Other Efficacy Outcome - Rescue Metrics | 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:
| 36 weeks |
| Assess Safety Outcome - Safety and Tolerability | Number of participants with treatment-emergent adverse event (TEAE) | 36 weeks |
| Ocular Safety and Tolerability | Ocular Safety is evaluated by incidence of ocular Treatment Emergent Adverse Events (TEAEs). | 36 weeks |
| Beverly Hills |
| California |
| 90211 |
| United States |
| Salehi Retina Institute Inc. | Huntington Beach | California | 92647 | United States |
| Bay Area Retina Associates | Walnut Creek | California | 94598 | United States |
| Advanced Vision Research Institute | Longmont | Colorado | 80503 | United States |
| Rand Eye Institute | Deerfield Beach | Florida | 33064 | United States |
| Florida Eye Associates | Melbourne | Florida | 32901 | United States |
| Retina Vitreous Associates of Florida | St. Petersburg | Florida | 33711 | United States |
| University Retina and Macula Associates | Lemont | Illinois | 60439 | United States |
| Midwest Eye | Carmel | Indiana | 46290 | United States |
| Cumberland Valley Retina Consultants | Hagerstown | Maryland | 21740 | United States |
| Sierra Eye Associates | Reno | Nevada | 89502 | United States |
| EyeHealth Northwest | Portland | Oregon | 97225 | United States |
| Erie Retina Research, LLC | Erie | Pennsylvania | 16507 | United States |
| Vision Research Solutions, PLLC | Philadelphia | Pennsylvania | 19141 | United States |
| Retina Consultants of Carolina | Greenville | South Carolina | 29605 | United States |
| Retina Research Institution of Texas | Abilene | Texas | 79606 | United States |
| Austin Retina Associates | Round Rock | Texas | 78681 | United States |
| Retina Center of Texas | Southlake | Texas | 76092 | United States |
| FG001 |
| Foselutoclax Arm |
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. Aflibercept: Anti-VEGF control foselutoclax: Experimental drug |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Anti-VEGF Control Arm | 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. Aflibercept: Anti-VEGF control |
| BG001 | Foselutoclax Arm | 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. Aflibercept: Anti-VEGF control foselutoclax: Experimental drug |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter | 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 | Posted | Least Squares Mean | Standard Error | change in ETDRS letters | Week 24 |
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| Secondary | Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36 | Changes in BCVA (ETDRS letters) from baseline to Week 36 | Posted | Least Squares Mean | Standard Error | change in ETDRS letters | 36 weeks |
|
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| Secondary | Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36 | Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 36 | Posted | Least Squares Mean | Standard Error | microns | 36 weeks |
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| Secondary | Assess Other Efficacy Outcome - Rescue Metrics | 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:
| Posted | Number | percentage of participants | 36 weeks |
| ||||||||||||||||||||||||||||||||
| Secondary | Assess Safety Outcome - Safety and Tolerability | Number of participants with treatment-emergent adverse event (TEAE) | Posted | Count of Participants | Participants | 36 weeks |
|
| |||||||||||||||||||||||||||||||
| Secondary | Ocular Safety and Tolerability | Ocular Safety is evaluated by incidence of ocular Treatment Emergent Adverse Events (TEAEs). | Subjects with at least one ocular TEAE in study eye | Posted | Count of Participants | Participants | 36 weeks |
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Consent through Study Week 36, including a 12 week run-in period (for a total of 48 weeks). After the subject consented and completed all screening procedures confirming eligibility, they proceeded to the Run-in period to receive 3 injections of aflibercept 4 weeks apart.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anti-VEGF Control Arm - Run-In Period | Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. | 0 | 26 | 0 | 26 | 2 | 26 |
| EG001 | Foselutoclax Arm - Run-In Period | Prior to randomization, participants will receive 3 IVT injections of aflibercept over 4-week intervals. | 0 | 26 | 0 | 26 | 0 | 26 |
| EG002 | Anti-VEGF Control Arm | 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. Aflibercept: Anti-VEGF control | 0 | 26 | 5 | 26 | 15 | 26 |
| EG003 | Foselutoclax Arm | 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. Aflibercept: Anti-VEGF control foselutoclax: Experimental drug | 0 | 26 | 5 | 26 | 22 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal detachment | Eye disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Systematic Assessment |
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| Localized Infection | Infections and infestations | Systematic Assessment |
| ||
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Subdural Haematoma | Injury, poisoning and procedural complications | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Shock hypoglycaemic | Metabolism and nutrition disorders | Systematic Assessment |
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| Lung Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Renal Failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Hypotension | Vascular disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diabetic retinal oedema (Study eye) | Eye disorders | Systematic Assessment |
| ||
| Conjunctival haemorrhage (Study eye) | Eye disorders | Systematic Assessment |
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| Conjunctival hyperaemia (Study eye) | Eye disorders | Systematic Assessment |
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| Punctate keratitis (Study eye) | Eye disorders | Systematic Assessment |
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| Diabetic retinal oedema (non-study eye) | Eye disorders | Systematic Assessment |
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| Posterior capsule opacification (Study eye) | Eye disorders | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | Systematic Assessment |
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| Corneal abrasion | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Urinary retention | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anirvan Ghosh | Unity Biotechnology, Inc. | - | anirvan.ghosh@unitybiotechnology.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2025 | Jun 13, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D008269 | Macular Edema |
| D003920 | Diabetes Mellitus |
| D003930 | Diabetic Retinopathy |
| D012162 | Retinal Degeneration |
| D005128 | Eye Diseases |
| D004487 | Edema |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D015785 | Eye Diseases, Hereditary |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Participants |
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