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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04857996
Other study ID # UBX1325-02
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 25, 2021
Est. completion date April 6, 2023

Study information

Verified date April 2024
Source Unity Biotechnology, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date April 6, 2023
Est. primary completion date April 6, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
UBX1325
Patients will be administered a single 50 µL UBX1325 IVT injection
Other:
Sham
Sham procedure

Locations

Country Name City State
Canada Alberta Retina Research Corporation Edmonton Alberta
Canada Hopital Maisonneuve-Rosemont Montréal Quebec
Canada Toronto Retina Institute North York Ontario
United States California Retina Consultants Bakersfield California
United States Mass Eye and Ear Institute Boston Massachusetts
United States Northwestern Medical Group Chicago Illinois
United States The Retina Partners Encino California
United States Retina Consultants of Carolina, PA Greenville South Carolina
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Salehi Retina Institute Inc. Huntington Beach California
United States MidWest Eye Institute Indianapolis Indiana
United States Loma Linda University Loma Linda California
United States Advanced Vision Research Institute Longmont Colorado
United States Valley Retina Institute, P.A. McAllen Texas
United States Bascom Palmer Eye Institute Miami Florida
United States MedEye Associates Miami Florida
United States New York Eye and Ear Infirmary New York New York
United States California Retina Consultants Oxnard California
United States Retinal Research Institute, LLC Phoenix Arizona
United States EyeHealth Northwest Portland Oregon
United States Sierra Eye Associates Reno Nevada
United States Retina Center of Texas Southlake Texas

Sponsors (1)

Lead Sponsor Collaborator
Unity Biotechnology, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Changes in Best Corrected Visual Acuity (BCVA) From Baseline Best Corrected Visual Acuity was assessed using the ETDRS chart starting at 4 meters Week 12, 24 and 48
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