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

Last updated: May 13, 2025
Sponsor: Unity Biotechnology, Inc.
Overall Status: Completed

Phase

2

Condition

Diabetic Retinopathy

Macular Edema

Eye Disease

Treatment

Aflibercept

foselutoclax

Clinical Study ID

NCT06011798
UBX1325-04
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Concurrent disease in the study eye (SE) or structural damage, other than DME, thatcould compromise BCVA, prevent BCVA improvement, require medical or surgicalintervention during the study period, confound interpretation of the results, orinterfere 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 eithereye.

  • Any medical condition that is uncontrolled and may prevent participation in thisstudy, as determined by the Investigator or disqualify individuals from enrollment.

Study Design

Total Participants: 52
Treatment Group(s): 2
Primary Treatment: Aflibercept
Phase: 2
Study Start date:
August 23, 2023
Estimated Completion Date:
April 08, 2025

Study 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.

Connect with a study center

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Site Not Available

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Salehi Retina Institute Inc.

    Huntington Beach, California 92647
    United States

    Site Not Available

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Advanced Vision Research Institute

    Longmont, Colorado 80503
    United States

    Site Not Available

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Site Not Available

  • Florida Eye Associates

    Melbourne, Florida 32901
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • University Retina and Macula Associates

    Lemont, Illinois 60439
    United States

    Site Not Available

  • Midwest Eye

    Carmel, Indiana 46290
    United States

    Site Not Available

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland 21740
    United States

    Site Not Available

  • Deep Blue Retina Clinical Research, PLLC

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Site Not Available

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Site Not Available

  • EyeHealth Northwest

    Portland, Oregon 97225
    United States

    Site Not Available

  • Erie Retina Research, LLC

    Erie, Pennsylvania 16507
    United States

    Site Not Available

  • Vision Research Solutions, PLLC

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • Retina Consultants of Carolina

    Greenville, South Carolina 29605
    United States

    Site Not Available

  • Retina Research Institution of Texas

    Abilene, Texas 79606
    United States

    Site Not Available

  • Austin Retina Associates

    Round Rock, Texas 78681
    United States

    Site Not Available

  • Retina Center of Texas

    Southlake, Texas 76092
    United States

    Site Not Available

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