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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04857996
Recruitment Status : Completed
First Posted : April 23, 2021
Last Update Posted : April 19, 2023
Sponsor:
Information provided by (Responsible Party):
Unity Biotechnology, Inc.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema (DME) Drug: UBX1325 Other: Sham Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: 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.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 25, 2021
Actual Primary Completion Date : April 6, 2023
Actual Study Completion Date : April 6, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
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Arm Intervention/treatment
Experimental: UBX1325 Drug: UBX1325
Patients will be administered a single 50 μL UBX1325 IVT injection
Sham Comparator: Sham Control Other: Sham
Sham procedure


Outcome Measures
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Primary Outcome Measures :
  1. Ocular and systemic safety and tolerability of a single IVT injection of UBX1325 evaluated by incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Changes in best corrected visual acuity (BCVA) from Baseline [ Time Frame: Week 12, 24 and 48 ]
  2. Proportion of patients who require 2 or more anti-VEGF rescue [ Time Frame: Week 12, 24 and 48 ]
  3. Change in central subfield thickness (CST) from baseline to each study visit as assessed by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Week 12, 24 and 48 ]
  4. Change in CST area under the curve (AUC) from baseline to each study visit [ Time Frame: Week 12, 24 and 48 ]
  5. Proportion of patients without macular fluid as assessed by SD-OCT [ Time Frame: Week 12, 24 and 48 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04857996


Locations
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Sponsors and Collaborators
Unity Biotechnology, Inc.
More Information
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Responsible Party: Unity Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT04857996    
Other Study ID Numbers: UBX1325-02
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 19, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Unity Biotechnology, Inc.:
Retinal disease
Macular edema
Diabetes mellitus
Diabetic macular edema
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases