NCT05275205

Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)

A Phase 2, Prospective, Multicenter, Randomized, Double-Masked, Active-Controlled Study to Assess the Safety, Tolerability, and Evidence of Activity of a Repeat Intravitreal Injection of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (Wet AMD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Unity Biotechnology, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.

Detailed description

This is a Phase 2 study. During Screening, every patient will receive a run-in injection of aflibercept. On Day 1, patients will be randomized to either the UBX1325 arm or the aflibercept arm. Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28; and sham procedure on Weeks 8, 16, 24, 32, and 40. Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.

Conditions

• Neovascular Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	UBX1325 injection 50 μL	Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
DRUG	EYLEA® (aflibercept) Injection 2 mg (0.05mL)	Patients randomized to the active-control aflibercept arm will receive aflibercept per label every 8 weeks starting from day 1 until Week 40. In addition, these patients will receive UBX1325 on Week 24 and Week 32; and a sham procedure at Week 4 and Week 28.

Timeline

• Start date: 2022-03-02
• Primary completion: 2023-02-15
• Completion: 2023-07-25
• First posted: 2022-03-11
• Last updated: 2024-08-07
• Results posted: 2024-08-07

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study