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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Drug: UBX1325 injection 50 μL
* Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UBX1325<br> | Drug: UBX1325 injection 50 μL<br>* Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28<br>|
| Active Comparator: Aflibercept (EYLEA ®)<br> | Drug: EYLEA® (aflibercept) Injection 2 mg (0.05mL)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Through 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 SD-OCT and read by a Central Reading Center |  | Through 48 weeks | 
| Adverse events (safety) |  | Through 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wet AMD