NCT04857996

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Unity Biotechnology, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	UBX1325	Patients will be administered a single 50 μL UBX1325 IVT injection
OTHER	Sham	Sham procedure

Timeline

• Start date: 2021-06-25
• Primary completion: 2023-04-06
• Completion: 2023-04-06
• First posted: 2021-04-23
• Last updated: 2024-05-16
• Results posted: 2024-05-16

Locations

22 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study