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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04857996




Registration number
NCT04857996
Ethics application status
Date submitted
21/04/2021
Date registered
23/04/2021
Date last updated
26/10/2023

Titles & IDs
Public title
Safety, Tolerability and Evidence of Activity Study of UBX1325 in Patients With Diabetic Macular Edema (BEHOLD)
Scientific 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
Secondary ID [1] 0 0
UBX1325-02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetic Macular Edema (DME) 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - UBX1325
Other interventions - Sham

Experimental: UBX1325 -

Sham Comparator: Sham Control -


Treatment: Drugs: UBX1325
Patients will be administered a single 50 µL UBX1325 IVT injection

Other interventions: Sham
Sham procedure
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ocular and systemic safety and tolerability of a single IVT injection of UBX1325 evaluated by incidence of treatment emergent adverse events (TEAEs)
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Changes in best corrected visual acuity (BCVA) from Baseline
Timepoint [1] 0 0
Week 12, 24 and 48
Secondary outcome [2] 0 0
Proportion of patients who require 2 or more anti-VEGF rescue
Timepoint [2] 0 0
Week 12, 24 and 48
Secondary outcome [3] 0 0
Change in central subfield thickness (CST) from baseline to each study visit as assessed by spectral domain optical coherence tomography (SD-OCT)
Timepoint [3] 0 0
Week 12, 24 and 48
Secondary outcome [4] 0 0
Change in CST area under the curve (AUC) from baseline to each study visit
Timepoint [4] 0 0
Week 12, 24 and 48
Secondary outcome [5] 0 0
Proportion of patients without macular fluid as assessed by SD-OCT
Timepoint [5] 0 0
Week 12, 24 and 48

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/04/2023
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Oregon
Country [12] 0 0
United States of America
State/province [12] 0 0
South Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
Canada
State/province [14] 0 0
Alberta
Country [15] 0 0
Canada
State/province [15] 0 0
Ontario
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Unity Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT04857996
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Sharon Klier, MD, MPH
Address 0 0
Unity Biotechnology, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04857996