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

• ClinicalTrials.gov Identifier: NCT05275205
• Recruitment Status: Active, not recruiting
• First Posted: March 11, 2022
• Last Update Posted: April 20, 2023
• Sponsor: Unity Biotechnology, Inc.
• Information provided by (Responsible Party): Unity Biotechnology, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Neovascular Age-related Macular Degeneration	Drug: UBX1325 injection 50 μL; Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL)	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)

Masking Description

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.

• Primary Purpose: Treatment
• Official Title: 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)
• Actual Study Start Date: March 2, 2022
• Actual Primary Completion Date: February 15, 2023
• Estimated Study Completion Date: August 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: UBX1325	Drug: UBX1325 injection 50 μL; Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
Active Comparator: Aflibercept (EYLEA ®)	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.

Outcome Measures

Primary Outcome Measures :

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 [ Time Frame: Through 24 weeks ]

Secondary Outcome Measures :

1. Change in best corrected visual acuity (BCVA) from Baseline over time [ Time Frame: Through 48 weeks ]
2. Change in central subfield thickness (CST) from Baseline over time as assessed by SD-OCT and read by a Central Reading Center [ Time Frame: Through 48 weeks ]
3. Adverse events (safety) [ Time Frame: Through 48 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 50 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States, 90211

Salehi Retina Institute

Huntington Beach, California, United States, 92647

United States, Colorado

Advanced Vision Research Institute

Longmont, Colorado, United States, 80503

United States, Florida

Rand Eye Institute

Deerfield Beach, Florida, United States, 33064

Retina Vitreous Associates of Florida

Saint Petersburg, Florida, United States, 33711

United States, Illinois

University Retina and Macula Associates

Lemont, Illinois, United States, 60439

Illinois Eye Center

Peoria, Illinois, United States, 61615

United States, Indiana

Midwest Eye

Carmel, Indiana, United States, 46290

United States, Minnesota

Mayo Clinic-Rochester

Rochester, Minnesota, United States, 55905

United States, Nevada

Sierra Eye Associates

Reno, Nevada, United States, 89502

United States, Oregon

EyeHealth Northwest

Portland, Oregon, United States, 97225

United States, Texas

Retina Research Institution of Texas

Abilene, Texas, United States, 79606

Valley Retina Institute

McAllen, Texas, United States, 78503

Austin Retina Associates

Round Rock, Texas, United States, 78681

Sponsors and Collaborators

Unity Biotechnology, Inc.

More Information

• Responsible Party: Unity Biotechnology, Inc.
• ClinicalTrials.gov Identifier: NCT05275205
• Other Study ID Numbers: UBX1325-03
• First Posted: March 11, 2022
• Last Update Posted: April 20, 2023
• Last Verified: April 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Unity Biotechnology, Inc.:

Wet AMD

Additional relevant MeSH terms:

Macular Degeneration; Wet Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Aflibercept; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents