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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06011798
Other study ID # UBX1325-04
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date August 23, 2023
Est. completion date June 2025

Study information

Verified date May 2024
Source Unity Biotechnology, Inc.
Contact Sharon Klier, MD, MPH
Phone 650-513-0096
Email UBX1325_medicalmonitor@unitybiotechnology.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date June 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Drug:
Aflibercept
Anti-VEGF control
foselutoclax
Experimental drug

Locations

Country Name City State
United States Retina Research Institution of Texas Abilene Texas
United States California Retina Consultants Bakersfield California
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Envision Ocular, LLC Bloomfield New Jersey
United States Midwest Eye Carmel Indiana
United States Rand Eye Institute Deerfield Beach Florida
United States Erie Retina Research, LLC Erie Pennsylvania
United States Retina Consultants of Carolina Greenville South Carolina
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Salehi Retina Institute Inc. Huntington Beach California
United States University Retina and Macula Associates Lemont Illinois
United States Advanced Vision Research Institute Longmont Colorado
United States Florida Eye Associates Melbourne Florida
United States Vision Research Solutions, PLLC Philadelphia Pennsylvania
United States EyeHealth Northwest Portland Oregon
United States Sierra Eye Associates Reno Nevada
United States Austin Retina Associates Round Rock Texas
United States Retina Vitreous Associates of Florida Saint Petersburg Florida
United States Deep Blue Retina Clinical Research, PLLC Southaven Mississippi
United States Retina Center of Texas Southlake Texas
United States Bay Area Retina Associates Walnut Creek California

Sponsors (1)

Lead Sponsor Collaborator
Unity Biotechnology, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mean change from baseline in BCVA by ETDRS letter Mean change from baseline in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter 24 weeks
Secondary Assess other efficacy outcome - Changes in BCVA Changes in BCVA (ETDRS letters) from baseline to each visit through Week 36 24 and 36 weeks
Secondary Assess other efficacy outcome - Changes in CST Change in Central Subfield Thickness (CST) as measured in microns from baseline to each visit through Week 36 24 and 36 weeks
Secondary Assess other efficacy outcome - ETDRS gains Proportion of participants gaining =15, =10, =5, or =0 ETDRS letters in BCVA from baseline in the Study Eye (SE) to Week 36 24 and 36 weeks
Secondary Assess other efficacy outcome - Rescue metrics Proportion of participants who do not require rescue 24 and 36 weeks
Secondary Assess safety outcome - TEAE Percentage of participants with at least one treatment-emergent ocular adverse event (AE) in the SE or Fellow Eye (FE) 24 and 36 weeks
Secondary Assess other efficacy outcome - Changes in BCVA Changes in BCVA from baseline to last observation at or prior to Week 36 24 and 36 weeks
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