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

NCT ID: NCT05275205

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-02
• Study Completion Date: 2023-07-25

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

UBX1325

Group Type: EXPERIMENTAL

UBX1325 injection 50 μL

Intervention Type: DRUG

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

Aflibercept (EYLEA ®)

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: 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.

Interventions

UBX1325 injection 50 μL

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients aged ≥50 years.
• Active CNV associated with age-related macular degeneration as evidenced on FA and SD-OCT with presence of intraretinal or subretinal fluid at Screening and Day 1
• BCVA in the study eye (most affected) of 70 to 20 ETDRS letters (equivalent to 20/40 to 20/400 on the Snellen chart) at Screening.
• Patients who have the capacity to give informed consent and who are willing and able to comply with all study-related procedures and assessments.

Exclusion Criteria

• Concurrent disease in the study eye or structural damage, other than wet AMD, 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 CFP in the study eye.
• Any ocular/intraocular/periocular infection or inflammation in either eye in the past 12 weeks prior to screening
• Subretinal hemorrhage with bleeding area of 4 or greater disc area in the study eye
• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unity Biotechnology, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sharon Klier, MD, MPH

Role: STUDY_DIRECTOR

Unity Biotechnology, Inc.

Locations

Midwest Eye

Carmel, Indiana, United States

Mayo Clinic-Rochester

Rochester, Minnesota, United States

Sierra Eye Associates

Reno, Nevada, United States

EyeHealth Northwest

Portland, Oregon, United States

Retina Research Institution of Texas

Abilene, Texas, United States

Valley Retina Institute

McAllen, Texas, United States

Austin Retina Associates

Round Rock, Texas, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Salehi Retina Institute

Huntington Beach, California, United States

Advanced Vision Research Institute

Longmont, Colorado, United States

Rand Eye Institute

Deerfield Beach, Florida, United States

Retina Vitreous Associates of Florida

St. Petersburg, Florida, United States

University Retina and Macula Associates

Lemont, Illinois, United States

Illinois Eye Center

Peoria, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

UBX1325-03

Identifier Type: -

Identifier Source: org_study_id