Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)

NCT04857996 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UBX1325-02
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 22

Brief Summary

This study is intended to assess the exposure, safety, biological activity, and durability of UBX1325, a phosphate pro-drug, and its active parent molecule (UBX0601) following a single intravitreal (IVT) injection of UBX1325 in patients with diabetic macular edema (DME).

Conditions

Diabetic Macular Edema (DME)

Keywords

Retinal disease; Macular edema; Diabetes mellitus; Diabetic macular edema

Outcome Measures

Primary Outcomes (2)

• Systemic Safety and Tolerability of a Single IVT Injection of UBX1325.

  The systemic safety and tolerability is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs) by System organ class Preferred Term.

  48 weeks

• Ocular Safety and Tolerability of a Single IVT Injection of UBX1325

  Ocular Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs). Ocular TEAEs consisted of progression of disease or were related to the IVT injection component of the UBX1325 drug administration process

  Up to Week 12, 24 and 48 weeks

Secondary Outcomes (1)

• Changes in Best Corrected Visual Acuity (BCVA) From Baseline

  Week 12, 24 and 48

Study Arms (2)

UBX1325

EXPERIMENTAL

Drug: UBX1325

Sham Control

SHAM COMPARATOR

Other: Sham

Interventions

UBX1325 DRUG

Patients will be administered a single 50 μL UBX1325 IVT injection

UBX1325

Sham OTHER

Sham procedure

Sham Control

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.
• Diabetic retinopathy patients (nonproliferative (NPDR) and proliferative (PDR)) with DME (ETDRS-DRSS Score at 65C \[or DR severity level of 8\]or less severe as determined by a Central Reading Center), who had at least 2 anti-VEGF intravitreal (IVT) injections (one or more of the following agents: aflibercept, bevacizumab or ranibizumab) in the preceding 6 months prior to Day 1, with the last anti-VEGF given between 3 and 6 weeks prior to Day 1.
• Center-involved DME with central subfield thickness (CST) ≥300 µm on SD-OCT at Screening
• BCVA in the study eye (most affected) of 73 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening and at Day 1.

You may not qualify if:

• Concurrent disease in the study eye 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 study eye.
• Any ocular/intraocular/periocular infection or inflammation in either eye in the past 4 weeks prior to screening
• History of vitreous hemorrhage in the study eye within 2 months prior to Screening
• Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator, constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct, or evaluation or prevent the patient from fully participating in all aspects of the study
• Significant media opacities, including cataract, which might interfere with VA, assessment of toxicity, or fundus imaging

Sponsors & Collaborators

• Unity Biotechnology, Inc.: lead

Study Sites (22)

Retinal Research Institute, LLC

Phoenix, Arizona, 85053, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

The Retina Partners

Encino, California, 91436, United States

Location

Salehi Retina Institute Inc.

Huntington Beach, California, 92647, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

California Retina Consultants

Oxnard, California, 93036, United States

Location

Advanced Vision Research Institute

Longmont, Colorado, 80503, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

MedEye Associates

Miami, Florida, 33143, United States

Location

Northwestern Medical Group

Chicago, Illinois, 60611, United States

Location

MidWest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Mass Eye and Ear Institute

Boston, Massachusetts, 02114, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

New York Eye and Ear Infirmary

New York, New York, 10003, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Retina Consultants of Carolina, PA

Greenville, South Carolina, 29605, United States

Location

Valley Retina Institute, P.A.

McAllen, Texas, 78503, United States

Location

Retina Center of Texas

Southlake, Texas, 76092, United States

Location

Alberta Retina Research Corporation

Edmonton, Alberta, T5H OX5, Canada

Location

Toronto Retina Institute

North York, Ontario, M3C 0G9, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Related Publications (1)

• Klier S, Dananberg J, Masaki L, Bhisitkul RB, Khanani AM, Maturi R, Salehi-Had H, Mallinckrodt CH, Rathmell JM, Ghosh A, Sapieha P. Safety and Efficacy of Senolytic UBX1325 in Diabetic Macular Edema. NEJM Evid. 2025 May;4(5):EVIDoa2400009. doi: 10.1056/EVIDoa2400009. Epub 2025 Apr 22.

  PMID: 40261111 DERIVED

MeSH Terms

Conditions

Retinal Diseases; Macular Edema; Diabetes Mellitus

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye Diseases; Macular Degeneration; Retinal Degeneration; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Unity Biotechnology, Inc.

UBX1325_medicalmonitor@unitybiotechnology.com

650-513-0096

Study Officials

• Sharon Klier, MD, MPH

  Unity Biotechnology, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study will be double masked, so patients and Investigators are masked to the treatment assigned, while certain roles at the site and at the Sponsor are unmasked. Sites will have a qualified injector who is unmasked to perform the study treatment injection or sham procedure, as well as certain post-injection assessments on Day 1 only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 23, 2021
• Study Start: June 25, 2021
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: May 16, 2024
• Results First Posted: May 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); US (19)