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

NCT06011798 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UBX1325-04
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 19

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

Conditions

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

Keywords

DME

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline to Average of Week 20 and Week 24 in BCVA by ETDRS Letter

  Mean change from baseline to the average of Week 20 and Week 24 in Best-Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) letter

  Week 24

Secondary Outcomes (5)

• Assess Other Efficacy Outcome - Changes in BCVA From Baseline to Week 36

  36 weeks

• Assess Other Efficacy Outcome - Changes in CST From Baseline to Week 36

  36 weeks

• Assess Other Efficacy Outcome - Rescue Metrics

  36 weeks

• Assess Safety Outcome - Safety and Tolerability

  36 weeks

• Ocular Safety and Tolerability

  36 weeks

Study Arms (2)

Anti-VEGF control arm

ACTIVE COMPARATOR

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

foselutoclax arm

EXPERIMENTAL

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; Drug: foselutoclax

Interventions

Aflibercept DRUG

Anti-VEGF control

Anti-VEGF control arm; foselutoclax arm

foselutoclax DRUG

Experimental drug

Also known as: UBX1325

foselutoclax arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Unity Biotechnology, Inc.: lead

Study Sites (19)

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Salehi Retina Institute Inc.

Huntington Beach, California, 92647, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Advanced Vision Research Institute

Longmont, Colorado, 80503, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

University Retina and Macula Associates

Lemont, Illinois, 60439, United States

Location

Midwest Eye

Carmel, Indiana, 46290, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Erie Retina Research, LLC

Erie, Pennsylvania, 16507, United States

Location

Vision Research Solutions, PLLC

Philadelphia, Pennsylvania, 19141, United States

Location

Retina Consultants of Carolina

Greenville, South Carolina, 29605, United States

Location

Retina Research Institution of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Round Rock, Texas, 78681, United States

Location

Retina Center of Texas

Southlake, Texas, 76092, United States

Location

MeSH Terms

Conditions

Retinal Diseases; Macular Edema; Diabetes Mellitus; Diabetic Retinopathy; Retinal Degeneration; Eye Diseases; Edema

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Eye Diseases, Hereditary; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anirvan Ghosh
• Organization: Unity Biotechnology, Inc.

anirvan.ghosh@unitybiotechnology.com

-

Study Officials

• Robert Bhisitkul, MD, Ph.D.

  Unity Biotechnology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 25, 2023
• Study Start: August 23, 2023
• Primary Completion: January 21, 2025
• Study Completion: April 8, 2025
• Last Updated: August 5, 2025
• Results First Posted: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (19)