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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011798
• Other study ID #: UBX1325-04
• Status: Recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Macular Edema
• Diabetic Retinopathy
• Edema
• Eye Diseases
• Macular Edema
• Retinal Degeneration
• Retinal Disease
• Retinal Diseases

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