CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
UBX1325 injection 50 μL +1 moredrug
Likely dose
EYLEA® (aflibercept) Injection 2 mg (0.05mL)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05275205
NCT05275205Phase 2Completed

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)

Unity Biotechnology, Inc.·interventional·Posted Mar 11, 2022·Updated Aug 7, 2024

In Brief

A Phase 2 clinical trial evaluating UBX1325 injection 50 μL and EYLEA® (aflibercept) Injection 2 mg (0.05mL) for Neovascular Age-related Macular Degeneration. Completed, enrolled 51 participants across 14 sites.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedMar 11, 2022
Enrollment StartMar 2, 2022
Primary CompletionFeb 15, 2023
Study CompletionJul 25, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 4.3 years ago

Interventions

UBX1325 injection 50 μLdrug

Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28

EYLEA® (aflibercept) Injection 2 mg (0.05mL)drug

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.