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Completed

NCT Number: NCT04857996

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

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).

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Key information

Conditions

Diabetic Macular Edema (DME) Diabetes Mellitus Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Macular Edema Metabolic Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alberta Retina Research Corporation, Edmonton, Alberta, Canada

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About this study

This is a Phase 2a Proof-of-Concept (POC) study. The study will enroll approximately 62 patients randomized 1:1 into either the UBX1325 or sham study arms, in order to assess safety and tolerability as well as impact on visual function and retinal anatomy. Patients will be followed for 24 weeks for the primary outcome measure and for an additional 24 weeks (48 weeks total) for the secondary outcome measures.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

UBX1325

Drug

Patients will be administered a single 50 μL UBX1325 IVT injection

SHAM

Other

Sham procedure

Primary outcomes

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

    Time frame: 48 weeks

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

  2. Ocular Safety and Tolerability of a Single IVT Injection of UBX1325

    Time frame: Up to Week 12, 24 and 48 weeks

    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

Secondary outcomes

  1. Changes in Best Corrected Visual Acuity (BCVA) From Baseline

    Time frame: Week 12, 24 and 48

    Best Corrected Visual Acuity was assessed using the ETDRS chart starting at 4 meters

Sponsors and collaborators

Lead sponsor

Unity Biotechnology, Inc.

Industry

Registry information

Official study title

A Phase 2a, Prospective, Multicenter, Randomized, Double Masked, Sham-Controlled Study to Assess the Safety, Tolerability and Evidence of Activity of a Single Intravitreal Injection of UBX1325 in Patients With Diabetic Macular Edema

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 23, 2021
Registry last updated
May 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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