Safety and Efficacy of Two Regimens of Ranibizumab 0.5 mg in Chinese Patients With Neovascular AMD

Sponsor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Study ID
NCT02810808
Phase
PHASE4
Status
Unknown

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • 1+PRN — PROCEDURE
    PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month.
  • 3+PRN — PROCEDURE
    PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does.
  • Ranibizumab — DRUG
    Ranibizumab - a recombinant, humanized monoclonal antibody Fab that neutralizes all active forms of VEGF-A was recently approved by the Food and Drug Administration for the treatment of all angiographic subtypes of subfoveal neovascular age-related macular degeneration

Study Details

The study will evaluate the efficacy and safety of two different dosing regimens of ranibizumab (0.5 mg on BCVA by 1+PRN vs 3+PRN) in Chinese patients with wet AMD. This study is to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Key Dates

First listed
Jun 23, 2016
Start date
Dec 31, 2013
Status verified
Jun 2016
Primary completion
Sep 30, 2016
Completion
Jan 31, 2017

Study Design

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

Arms

  • Experimental: Ranibizumab 0.5 mg 1+PRN
    PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization in the 11 month treatment period Intervention: Drug: Ranibizumab
  • Active Comparator: Ranibizumab 0.5 mg 3+PRN
    PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization after three Monthly intravitreal injections of the same dose.

Primary Outcome Measure

Mean Snellen BCVA at every visit [ Time Frame: 12 months ]

Central Contacts

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