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Monoclonal Antibodies
Foselutoclax for Diabetic Macular Edema (ASPIRE Trial)
Phase 2
Waitlist Available
Research Sponsored by Unity Biotechnology, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients with nonproliferative DR and DME
Patients aged ≥18 years
Must not have
Significant media opacities, including cataract, or posterior capsule opacification, which might interfere with VA, assessment of toxicity, or fundus imaging in either eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 and 36 weeks
Awards & highlights
Summary
This trial is testing foselutoclax, a new drug, in patients with Diabetic Macular Edema who haven't responded to other treatments. The drug works by blocking a protein to reduce eye swelling and improve vision.
Who is the study for?
This trial is for adults over 18 with nonproliferative diabetic retinopathy and diabetic macular edema. Participants must have a certain level of central retina thickness and vision range. Those with other eye conditions, significant cataracts, or uncontrolled medical issues that could affect the study are not eligible.
What is being tested?
The trial tests the effectiveness and safety of foselutoclax (UBX1325) injections in comparison to aflibercept for treating diabetic macular edema. It aims to determine if foselutoclax can improve patients' vision better or as well as aflibercept while monitoring any side effects.
What are the potential side effects?
While specific side effects of foselutoclax are not listed here, intravitreal injections like those used in this trial may cause eye pain, bleeding inside the eye, inflammation, increased pressure inside the eye, and possibly temporary visual disturbances.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have non-growing diabetic retinopathy and swelling in my retina.
Select...
I am 18 years old or older.
Select...
My eye condition involves swelling in the center of my retina.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have eye conditions like cataracts that could affect my vision or eye exams.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 and 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 and 36 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean change from baseline in BCVA by ETDRS letter
Secondary study objectives
Assess other efficacy outcome - Changes in BCVA
Assess other efficacy outcome - Changes in CST
Assess other efficacy outcome - ETDRS gains
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: foselutoclax armExperimental Treatment2 Interventions
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.
Group II: Anti-VEGF control armActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aflibercept
2016
Completed Phase 4
~2550
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Macular Edema treatments often target the underlying causes of fluid accumulation in the macula. VEGF inhibitors, such as aflibercept, work by blocking vascular endothelial growth factor, reducing abnormal blood vessel growth and permeability, which helps decrease fluid leakage.
Corticosteroids reduce inflammation and stabilize blood-retinal barriers, also minimizing fluid accumulation. Foselutoclax, a Bcl-xL inhibitor, is being studied for its potential to induce apoptosis in abnormal cells, which may help in reducing macular edema by targeting cellular mechanisms contributing to fluid retention.
These treatments are crucial for Macular Edema patients as they directly address the pathological processes causing vision impairment, aiming to preserve and improve visual function.
Find a Location
Who is running the clinical trial?
Unity Biotechnology, Inc.Lead Sponsor
8 Previous Clinical Trials
622 Total Patients Enrolled
Robert Bhisitkul, MD, Ph.DStudy DirectorUnity Biotechnology, Inc.
Sharon Klier, MD, MPHStudy DirectorUnity Biotechnology, Inc.
2 Previous Clinical Trials
116 Total Patients Enrolled
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