Clinical trial NCT05275205: Safety, Tolerability, and Efficacy Study of UBX1325 in Patients With Neovascular Age-Related Macular Degeneration (ENVISION)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Wet AMD
Lead sponsor: Unity Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Through 24 weeks
Secondary outcomes:
measure: Change in Best Corrected Visual Acuity (BCVA) From Baseline Over Time
timeFrame: Through 48 weeks
measure: 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
timeFrame: Through 48 weeks
measure: Adverse Events (Safety)
timeFrame: Through 48 weeks
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Huntington Beach
country: United States
facility: Salehi Retina Institute
state: California
city: Longmont
country: United States
facility: Advanced Vision Research Institute
state: Colorado
city: Deerfield Beach
country: United States
facility: Rand Eye Institute
state: Florida
city: Saint Petersburg
country: United States
facility: Retina Vitreous Associates of Florida
state: Florida
city: Lemont
country: United States
facility: University Retina and Macula Associates
state: Illinois
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Carmel
country: United States
facility: Midwest Eye
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic-Rochester
state: Minnesota
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Portland
country: United States
facility: EyeHealth Northwest
state: Oregon
city: Abilene
country: United States
facility: Retina Research Institution of Texas
state: Texas
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: Round Rock
country: United States
facility: Austin Retina Associates
state: Texas
Study officials:
affiliation: Unity Biotechnology, Inc.
name: Sharon Klier, MD, MPH
role: STUDY_DIRECTOR
References: