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Monoclonal Antibodies

Foselutoclax for Diabetic Macular Edema (ASPIRE Trial)

Phase 2

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

ASPIRE Trial Summary

This trial will test a new drug to treat Diabetic Macular Edema to see if it is effective and safe.

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.Check my eligibility

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.See study design

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.

ASPIRE Trial 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.

Select...

My eye condition involves swelling in the center of my retina.

ASPIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Mean change from baseline in BCVA by ETDRS letter

Secondary outcome measures

Assess other efficacy outcome - Changes in BCVA

Assess other efficacy outcome - Changes in CST

Assess other efficacy outcome - ETDRS gains

+1 more

ASPIRE 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

~2540

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Unity Biotechnology, Inc.Lead Sponsor

8 Previous Clinical Trials

622 Total Patients Enrolled

2 Trials studying Macular Edema

84 Patients Enrolled for Macular Edema

Sharon Klier, MD, MPHStudy DirectorUnity Biotechnology, Inc.

2 Previous Clinical Trials

116 Total Patients Enrolled

1 Trials studying Macular Edema

65 Patients Enrolled for Macular Edema

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many locations are actively participating in this experiment?

"Eight medical centres are enrolling patients for this experiment, such as Bay Area Retina Associates in Walnut Creek, Advanced Vision Research Institute in Longmont and Rand Eye Institute in Deerfield Beach. Several other locations are also included."

Answered by AI

Has the FDA authorized the utilization of foselutoclax arm?

"Foselutoclax arm is estimated to be a 2 on the safety scale due to Phase 2 trial data, which suggests some support for its security but none for efficacy."

Answered by AI

Is enrollment into this research project still available?

"As per the records on clinicaltrials.gov, this particular medical trial is no longer actively seeking participants; it was initially posted in August of 2023 and its last edit occurred at the end of that month. Nonetheless, there are currently 1495 other trials looking for volunteers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)

2023. "Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06011798.

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