What side effects are associated with this type of intervention?

The most common treatments for Macular Edema, such as aflibercept and ranibizumab, are generally well-tolerated but can have side effects. These include mild to moderate injection site reactions like pain, redness, and bruising. Other potential side effects are increased intraocular pressure, cataracts, and retinal detachment. Rare but serious complications can include endophthalmitis, which is an infection inside the eye. Overall, these treatments are effective in reducing macular edema and improving visual acuity, with side effects being manageable in most cases.

What prior FDA approvals exist?

The FDA has approved several treatments for Macular Edema, particularly those involving intravitreal injections. Aflibercept, a vascular endothelial growth factor (VEGF) inhibitor, is one such drug that has been widely used. Other similar treatments include bevacizumab and ranibizumab, which also target VEGF to reduce fluid accumulation and swelling in the retina. While foselutoclax (a Bcl-xL inhibitor) is being studied for its efficacy and safety in treating Diabetic Macular Edema, it represents a novel approach compared to the VEGF inhibitors currently approved.

What other types of research exist?

Promising novel alternatives to Foselutoclax for Macular Edema patients in 2024 include Faricimab, a bispecific antibody targeting both VEGF and Ang-2, and KSI-301, an anti-VEGF antibody biopolymer conjugate. Both have shown positive results in recent clinical trials for DME.

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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

No Placebo-Only Group

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 below

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I have non-growing diabetic retinopathy and swelling in my retina.

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I am 18 years old or older.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 and 36 weeks for reporting.

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

0 / 4Eligibility criteria met

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.