TAB014 Compared to Lucentis® in Patients with Neovascular Age-related Macular Degeneration

Sponsor
BioDlink Biopharm Co., Ltd.
Study ID
NCT05461339
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • TAB014 Monoclonal Antibody Injection — DRUG
    intravitreal injection at 1.25mg once every 4 weeks
  • Ranibizumab Injection [Lucentis] — DRUG
    intravitreal injection at 0.5mg once every 4 weeks

Study Details

This study is a randomized, multi-center, double blind, Lucentis controlled non-inferiority study in neovascular age-related macular degeneration patients. The objective of this study is to compare the efficacy and safety of TAB014 and ranibizumab (Lucentis).

Key Dates

First listed
Jul 18, 2022
Start date
Jun 28, 2022
Status verified
Jan 2025
Primary completion
Sep 20, 2024
Completion
Feb 28, 2025

Study Design

Enrollment
488 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TAB014
    intravitreal injection at 1.25mg once every 4 week
  • Active Comparator: Ranibizumb
    intravitreal injection at 0.5mg once every 4 week

Primary Outcome Measure

Evaluate the change in BCVA of the study eye from TAB014 and ranibizumab treatment groups. [ Time Frame: At week 52 ]

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