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

Primary Purpose

Diabetic Macular Edema (DME)

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
UBX1325
Sham
Sponsored by
Unity Biotechnology, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema (DME) focused on measuring Retinal disease, Macular edema, Diabetes mellitus, Diabetic macular edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • Retinal Research Institute, LLC
  • California Retina Consultants
  • The Retina Partners
  • Salehi Retina Institute Inc.
  • Loma Linda University
  • California Retina Consultants
  • Advanced Vision Research Institute
  • Bascom Palmer Eye Institute
  • MedEye Associates
  • Northwestern Medical Group
  • MidWest Eye Institute
  • Cumberland Valley Retina Consultants
  • Mass Eye and Ear Institute
  • Sierra Eye Associates
  • New York Eye and Ear Infirmary
  • EyeHealth Northwest
  • Retina Consultants of Carolina, PA
  • Valley Retina Institute, P.A.
  • Retina Center of Texas
  • Alberta Retina Research Corporation
  • Toronto Retina Institute
  • Hopital Maisonneuve-Rosemont

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

UBX1325

Sham Control

Arm Description

Outcomes

Primary Outcome Measures

Ocular and systemic safety and tolerability of a single IVT injection of UBX1325 evaluated by incidence of treatment emergent adverse events (TEAEs)

Secondary Outcome Measures

Changes in best corrected visual acuity (BCVA) from Baseline
Proportion of patients who require 2 or more anti-VEGF rescue
Change in central subfield thickness (CST) from baseline to each study visit as assessed by spectral domain optical coherence tomography (SD-OCT)
Change in CST area under the curve (AUC) from baseline to each study visit
Proportion of patients without macular fluid as assessed by SD-OCT

Full Information

First Posted
April 21, 2021
Last Updated
April 17, 2023
Sponsor
Unity Biotechnology, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04857996
Brief Title
Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
April 6, 2023 (Actual)
Study Completion Date
April 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unity Biotechnology, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema (DME)
Keywords
Retinal disease, Macular edema, Diabetes mellitus, Diabetic macular edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
UBX1325
Arm Type
Experimental
Arm Title
Sham Control
Arm Type
Sham Comparator
Intervention Type
Drug
Intervention Name(s)
UBX1325
Intervention Description
Patients will be administered a single 50 μL UBX1325 IVT injection
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham procedure
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Changes in best corrected visual acuity (BCVA) from Baseline
Time Frame
Week 12, 24 and 48
Title
Proportion of patients who require 2 or more anti-VEGF rescue
Time Frame
Week 12, 24 and 48
Title
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
Title
Change in CST area under the curve (AUC) from baseline to each study visit
Time Frame
Week 12, 24 and 48
Title
Proportion of patients without macular fluid as assessed by SD-OCT
Time Frame
Week 12, 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
The Retina Partners
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Facility Name
Salehi Retina Institute Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
California Retina Consultants
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Facility Name
Advanced Vision Research Institute
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80503
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
MedEye Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Northwestern Medical Group
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
MidWest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Mass Eye and Ear Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
EyeHealth Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Retina Consultants of Carolina, PA
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Valley Retina Institute, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Retina Center of Texas
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Alberta Retina Research Corporation
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H OX5
Country
Canada
Facility Name
Toronto Retina Institute
City
North York
State/Province
Ontario
ZIP/Postal Code
M3C 0G9
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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