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

Diabetic Macular Edema (DME) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04857996
• Other study ID #: UBX1325-02
• Status: Completed
• Phase: Phase 2
• Start date: June 25, 2021
• Est. completion date: April 6, 2023

Study information

• Verified date: October 2023
• Source: Unity Biotechnology, Inc.
• Contact: n/a
• Is FDA regulated: No
• 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

Related Conditions & MeSH terms

• Diabetic Macular Edema (DME)
• Edema
• Macular Edema

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