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

Part of paid clinical trials in Bakersfield, California.

Sponsor
Unity Biotechnology, Inc.
Study ID
NCT06011798
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept — DRUG
    Anti-VEGF control
  • foselutoclax — DRUG
    Experimental drug

Study Details

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

Key Dates

Start date
Aug 23, 2023
Status verified
Jul 2025
Primary completion
Jan 21, 2025
Completion
Apr 8, 2025

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter [ Time Frame: Week 24 ]

Locations (19)

FacilityCityStateZIPSite coordinators
California Retina ConsultantsBakersfieldCalifornia93309-
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Salehi Retina Institute Inc.Huntington BeachCalifornia92647-
Bay Area Retina AssociatesWalnut CreekCalifornia94598-
Advanced Vision Research InstituteLongmontColorado80503-
Rand Eye InstituteDeerfield BeachFlorida33064-
Florida Eye AssociatesMelbourneFlorida32901-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-
University Retina and Macula AssociatesLemontIllinois60439-
Midwest EyeCarmelIndiana46290-
Cumberland Valley Retina ConsultantsHagerstownMaryland21740-
Sierra Eye AssociatesRenoNevada89502-
EyeHealth NorthwestPortlandOregon97225-
Erie Retina Research, LLCEriePennsylvania16507-
Vision Research Solutions, PLLCPhiladelphiaPennsylvania19141-
Retina Consultants of CarolinaGreenvilleSouth Carolina29605-
Retina Research Institution of TexasAbileneTexas79606-
Austin Retina AssociatesRound RockTexas78681-
Retina Center of TexasSouthlakeTexas76092-

Find similar trials in Bakersfield, CA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
California Retina Consultants· Bakersfield, CARetina-Vitreous Associates Medical Group· Beverly Hills, CASalehi Retina Institute Inc.· Huntington Beach, CABay Area Retina Associates· Walnut Creek, CAAdvanced Vision Research Institute· Longmont, CORand Eye Institute· Deerfield Beach, FL

Related Studies