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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Unity Biotechnology, Inc.
Study ID
NCT05275205
Phase
PHASE2
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UBX1325 injection 50 μL — DRUG
    Patients randomized to the UBX1325 arm will receive UBX1325 on Day 1, Weeks 4, 24, and 28
  • 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.

Study Details

This study is intended to assess safety, tolerability and biological activity of a repeat IVT injection of UBX1325 in patients with wet AMD.

Key Dates

Start date
Mar 2, 2022
Status verified
Oct 2023
Primary completion
Feb 15, 2023
Completion
Jul 25, 2023

Study Design

Enrollment
51 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: UBX1325
  • Active Comparator: Aflibercept (EYLEA ®)

Primary Outcome 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 [ Time Frame: Through 24 weeks ]

Locations (14)

FacilityCityStateZIPSite coordinators
Retina-Vitreous Associates Medical GroupBeverly HillsCalifornia90211-
Salehi Retina InstituteHuntington BeachCalifornia92647-
Advanced Vision Research InstituteLongmontColorado80503-
Rand Eye InstituteDeerfield BeachFlorida33064-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-
University Retina and Macula AssociatesLemontIllinois60439-
Illinois Eye CenterPeoriaIllinois61615-
Midwest EyeCarmelIndiana46290-
Mayo Clinic-RochesterRochesterMinnesota55905-
Sierra Eye AssociatesRenoNevada89502-
EyeHealth NorthwestPortlandOregon97225-
Retina Research Institution of TexasAbileneTexas79606-
Valley Retina InstituteMcAllenTexas78503-
Austin Retina AssociatesRound RockTexas78681-

Find similar trials in Beverly Hills, CA

By research site
Retina-Vitreous Associates Medical Group· Beverly Hills, CASalehi Retina Institute· Huntington Beach, CAAdvanced Vision Research Institute· Longmont, CORand Eye Institute· Deerfield Beach, FLRetina Vitreous Associates of Florida· St. Petersburg, FLUniversity Retina and Macula Associates· Lemont, IL

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