Diabetic Macular EdemaPhase 2NCT06011798
Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
A Phase 2 study testing Aflibercept and foselutoclax in people with Diabetic Macular Edema and Retinal Disease, run by Unity Biotechnology, Inc. at 19 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema, Retinal Disease, Macular Edema
- What is being tested?
- Aflibercept and foselutoclax
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 19 sitesUnited States
- Study dates
- 23 Aug 2023to 8 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Retina Research Institution of Texas
Abilene, Texas, 79606
California Retina Consultants
Bakersfield, California, 93309
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Midwest Eye
Carmel, Indiana, 46290
Rand Eye Institute
Deerfield Beach, Florida, 33064
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Retina Consultants of Carolina
Greenville, South Carolina, 29605
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Salehi Retina Institute Inc.
Huntington Beach, California, 92647
University Retina and Macula Associates
Lemont, Illinois, 60439
Advanced Vision Research Institute
Longmont, Colorado, 80503
Florida Eye Associates
Melbourne, Florida, 32901
Vision Research Solutions, PLLC
Philadelphia, Pennsylvania, 19141
EyeHealth Northwest
Portland, Oregon, 97225
Sierra Eye Associates
Reno, Nevada, 89502
Austin Retina Associates
Round Rock, Texas, 78681
Retina Center of Texas
Southlake, Texas, 76092
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
Official title: 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
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
Read the 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.
- Conditions
- Diabetic Macular Edema, Retinal Disease, Macular Edema, Diabetes Mellitus, Diabetic Retinopathy, Retinal Degeneration
- Being tested
- Aflibercept, foselutoclax
- Keywords
- DME
- Medical subject headings
- Retinal Diseases, Macular Edema, Diabetes Mellitus, Diabetic Retinopathy, Retinal Degeneration, Eye Diseases, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
Anti-VEGF control
foselutoclaxDrug
Also called UBX1325
Experimental drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Aflibercept |
| 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. Receives: Drug: Aflibercept; Drug: foselutoclax |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 24
Secondary outcomes (5)
Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36
Changes in BCVA (ETDRS letters) from baseline to Week 36
Measured: 36 weeks
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
Measured: 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:
- Worsening CST by ≥75 µm from baseline per SD-OCT
- A ≥10 letter decrease in BCVA compared to baseline
- New clinically significant blood or heme present compared to previous visit
- PI discretion (rationale to be documented in the EDC)
Measured: 36 weeks
Assess Safety Outcome - Safety and Tolerability
Number of participants with treatment-emergent adverse event (TEAE)
Measured: 36 weeks
Ocular Safety and Tolerability
Ocular Safety is evaluated by incidence of ocular Treatment Emergent Adverse Events (TEAEs).
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start23 Aug 2023
- Primary completion21 Jan 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Bhisitkul, MD, Ph.D., Study director, Unity Biotechnology, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011798
- Sponsor's protocol ID
- UBX1325-04
- Status last verified
- Jul 2025
- First submitted
- 2 Aug 2023
- Last updated
- 5 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06011798
- Acronym / sponsor ID
- UBX1325-04
- Conditions
- Diabetic Macular Edema, Retinal Disease, Macular Edema, Diabetes Mellitus, Diabetic Retinopathy, Retinal Degeneration
- Keywords
- DME
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Unity Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Aug 2023 (actual)
- Primary completion
- 21 Jan 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Posted 5 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-VEGF control arm | Active comparator | Drug: AfliberceptPrior 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 | Drug: Aflibercept, Drug: foselutoclaxPrior 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfliberceptAnti-VEGF control | Drug | Anti-VEGF control arm, foselutoclax arm |
| foselutoclaxAlso: UBX1325Experimental drug | Drug | foselutoclax arm |
Primary outcome
Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter
Time frame: Week 24
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
5 secondary outcomes
Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36
Time frame: 36 weeks
Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36
Time frame: 36 weeks
Assess Other Efficacy Outcome - Rescue Metrics
Time frame: 36 weeks
Assess Safety Outcome - Safety and Tolerability
Time frame: 36 weeks
Ocular Safety and Tolerability
Time frame: 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bhisitkul, MD, Ph.D. study director
Unity Biotechnology, Inc.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Aflibercept and foselutoclax in people with Diabetic Macular Edema and Retinal Disease, run by Unity Biotechnology, Inc. at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2025.