Clinical trial NCT06011798: Assess the Efficacy and Safety of Repeat Intravitreal Injections of Foselutoclax (UBX1325) in Patients With DME (ASPIRE)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Retinal Disease
Macular Edema
Diabetes Mellitus
Diabetic Retinopathy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Edema
Keywords: DME
Lead sponsor: Unity Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 questions the study aims to answer are:

* Assess the efficacy of foselutoclax compared to aflibercept
* Assess the safety and tolerability of foselutoclax

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in BCVA by ETDRS letter
timeFrame: 24 weeks
Secondary outcomes:
measure: Assess other efficacy outcome - Changes in BCVA
timeFrame: 24 and 36 weeks
measure: Assess other efficacy outcome - Changes in CST
timeFrame: 24 and 36 weeks
measure: Assess other efficacy outcome - ETDRS gains
timeFrame: 24 and 36 weeks
measure: Assess other efficacy outcome - Rescue metrics
timeFrame: 24 and 36 weeks
measure: Assess safety outcome - TEAE
timeFrame: 24 and 36 weeks
measure: Assess other efficacy outcome - Changes in BCVA
timeFrame: 24 and 36 weeks
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute Inc.
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Longmont
country: United States
facility: Advanced Vision Research Institute
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Lemont
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye
state: Indiana
city: Hagerstown
country: United States
facility: Cumberland Valley Retina Consultants
state: Maryland
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Erie
country: United States
facility: Erie Retina Research, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Vision Research Solutions, PLLC
state: Pennsylvania
city: Greenville
country: United States
facility: Retina Consultants of Carolina
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institution of Texas
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates
state: Texas
city: Southlake
country: United States
facility: Retina Center of Texas
state: Texas
Study officials:
affiliation: Unity Biotechnology, Inc.
name: Robert Bhisitkul, MD, Ph.D
role: STUDY_DIRECTOR
References: