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

October 24, 2023 updated by: Unity Biotechnology, Inc.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 40 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 24 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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Bakersfield, California, United States, 93309
        • Recruiting
        • California Retina Consultants
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Retina-Vitreous Associates Medical Group
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Salehi Retina Institute Inc.
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Bay Area Retina Associates
    • Colorado
      • Longmont, Colorado, United States, 80503
        • Recruiting
        • Advanced Vision Research Institute
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Recruiting
        • Rand Eye Institute
      • Melbourne, Florida, United States, 32901
        • Recruiting
        • Florida Eye Associates
      • Saint Petersburg, Florida, United States, 33711
        • Recruiting
        • Retina Vitreous Associates of Florida
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • University Retina and Macula Associates
    • Indiana
      • Carmel, Indiana, United States, 46290
        • Recruiting
        • Midwest Eye
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Sierra Eye Associates
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Recruiting
        • Envision Ocular, LLC
    • Oregon
      • Portland, Oregon, United States, 97225
        • Recruiting
        • EyeHealth Northwest
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16507
        • Recruiting
        • Erie Retina Research, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • Retina Consultants of Carolina
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Retina Research Institution of Texas
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Austin Retina Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Aflibercept
Anti-VEGF control
Experimental: 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.
Drug: Aflibercept
Anti-VEGF control
Drug: foselutoclax
Experimental drug
Other Names:
  • UBX1325

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change from baseline in BCVA by ETDRS letter
Time Frame: 24 weeks
Mean change from baseline in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess other efficacy outcome - Changes in BCVA
Time Frame: 24 weeks
Changes in BCVA (ETDRS letters) from baseline to visits prior to Week 24
24 weeks
Assess other efficacy outcome - Changes in CST
Time Frame: 24 weeks
Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 24
24 weeks
Assess other efficacy outcome - ETDRS gains
Time Frame: 24 weeks
Proportion of participants gaining ≥15, ≥10, ≥5, or ≥0 ETDRS letters in BCVA from baseline in the Study Eye (SE) to week 24
24 weeks
Assess safety outcome - TEAE
Time Frame: 24 weeks
Percentage of participants with at least one treatment-emergent ocular adverse event (AE) in the SE or Fellow Eye (FE)
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Biotechnology, Inc.

Investigators

  • Study Director: Sharon Klier, MD, MPH, Unity Biotechnology, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 23, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 2, 2023

First Submitted That Met QC Criteria

August 23, 2023

First Posted (Actual)

August 25, 2023

Study Record Updates

Last Update Posted (Actual)

October 27, 2023

Last Update Submitted That Met QC Criteria

October 24, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UBX1325-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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