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

NCT05275205 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-08-07

Study results available
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Summary

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

Conditions

  • Neovascular Age-related Macular Degeneration

Interventions

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.

Sponsors & Collaborators

  • Unity Biotechnology, Inc.

    lead INDUSTRY

Principal Investigators

  • Sharon Klier, MD, MPH · Unity Biotechnology, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-02
Primary Completion
2023-02-15
Completion
2023-07-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05275205 on ClinicalTrials.gov