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

NCT05275205 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: UBX1325-03
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 14

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

Wet AMD

Outcome Measures

Primary Outcomes (1)

• Treatment Emergent Adverse Events (TEAEs) Will be Evaluated for Ocular and Systemic Safety and Tolerability of a Repeat IVT Injection of UBX1325 Compared to Active Control

  Ocular and systemic safety and tolerability of a repeat IVT injection of UBX1325 compared to active-control (aflibercept) evaluated by treatment emergent adverse events (TEAEs) through Week 24

  Through 24 weeks

Secondary Outcomes (3)

• Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time

  Through 48 weeks

• Change in Central Subfield Thickness (CST) From Baseline Over Time as Assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) and Read by a Central Reading Center

  Through 48 weeks

• Adverse Events (Safety)

  Through 48 weeks

Study Arms (2)

UBX1325

EXPERIMENTAL

Drug: UBX1325 injection 50 μL

Aflibercept (EYLEA ®)

ACTIVE COMPARATOR

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

Interventions

UBX1325 injection 50 μL DRUG

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

UBX1325

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.

Aflibercept (EYLEA ®)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Biotechnology, Inc.: lead

Study Sites (14)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Salehi Retina Institute

Huntington Beach, California, 92647, United States

Location

Advanced Vision Research Institute

Longmont, Colorado, 80503, United States

Location

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Retina Vitreous Associates of Florida

St. Petersburg, Florida, 33711, United States

Location

University Retina and Macula Associates

Lemont, Illinois, 60439, United States

Location

Illinois Eye Center

Peoria, Illinois, 61615, United States

Location

Midwest Eye

Carmel, Indiana, 46290, United States

Location

Mayo Clinic-Rochester

Rochester, Minnesota, 55905, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Retina Research Institution of Texas

Abilene, Texas, 79606, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Austin Retina Associates

Round Rock, Texas, 78681, United States

Location

MeSH Terms

Interventions

aflibercept; Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Study Director
• Organization: Unity Biotechnology, Inc.

UBX1325_medicalmonitor@unitybiotechnology.com

650-513-0096

Study Officials

• Sharon Klier, MD, MPH

  Unity Biotechnology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study is double-masked, masking patients and investigators to treatment assignment. In addition to this, any Clinical Research Organization and Sponsor team members who are actively engaged with the site will be masked. The injector will be unmasked. Some additional roles at the site, Clinical Research Organization and Sponsor levels are unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2022
• First Posted: March 11, 2022
• Study Start: March 2, 2022
• Primary Completion: February 15, 2023
• Study Completion: July 25, 2023
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (14)