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

Sponsor
Unity Biotechnology, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06011798
Collaborator
(none)
40
Enrollment
8
Locations
2
Arms
16
Anticipated Duration (Months)
5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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 question[s] the study aims to answer are:

  • Assess the efficacy of foselutoclax compared to aflibercept

  • Assess the safety and tolerability of foselutoclax

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Mean change from baseline in BCVA by ETDRS letter [24 weeks]

      Mean change from baseline in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter

    Secondary Outcome Measures

    1. Assess other efficacy outcome - Changes in BCVA [24 weeks]

      Changes in BCVA (ETDRS letters) from baseline to visits prior to Week 24

    2. Assess other efficacy outcome - Changes in CST [24 weeks]

      Change in Central Subfield Thickness (CST) as measured in microns from baseline to Week 24

    3. Assess other efficacy outcome - ETDRS gains [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

    4. Assess safety outcome - TEAE [24 weeks]

      Percentage of participants with at least one treatment-emergent ocular adverse event (AE) in the SE or Fellow Eye (FE)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 California Retina Consultants Bakersfield California United States 93309
    2 Bay Area Retina Associates Walnut Creek California United States 94598
    3 Advanced Vision Research Institute Longmont Colorado United States 80503
    4 Rand Eye Institute Deerfield Beach Florida United States 33064
    5 Florida Eye Associates Melbourne Florida United States 32901
    6 EyeHealth Northwest Portland Oregon United States 97225
    7 Retina Consultants of Carolina Greenville South Carolina United States 29605
    8 Retina Center of Texas Southlake Texas United States 76092

    Sponsors and Collaborators

    • Unity Biotechnology, Inc.

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Unity Biotechnology, Inc.
    ClinicalTrials.gov Identifier:
    NCT06011798
    Other Study ID Numbers:
    • UBX1325-04
    First Posted:
    Aug 25, 2023
    Last Update Posted:
    Aug 25, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Unity Biotechnology, Inc.
    DME
    Additional relevant MeSH terms:
    Macular Edema
    Retinal Diseases
    Diabetic Retinopathy
    Eye Diseases
    Retinal Degeneration
    Edema
    Aflibercept

    Study Results

    No Results Posted as of Aug 25, 2023