This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
51
Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
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.
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
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
Time frame: Through 24 weeks
Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
BCVA was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart starting at 4 meters.
Time frame: 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
Central Subfield Thickness (CST) measured in microns using spectral domain optical coherence tomography (SD-OCT).
Time frame: Through 48 weeks
Adverse Events (Safety)
Safety is evaluated by incidence of Treatment Emergent Adverse Events (TEAEs).
Time frame: Through 48 weeks
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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
Midwest Eye
Carmel, Indiana, United States
Mayo Clinic-Rochester
Rochester, Minnesota, United States
Sierra Eye Associates
Reno, Nevada, United States
...and 4 more locations