Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese Patients With nAMD (Age Related Macular Degeneration)

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01775124
Phase
PHASE4
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Intravitreal injections of 0.5 mg Ranibizumab

Study Details

The study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.

Key Dates

First listed
Jan 24, 2013
Start date
Feb 22, 2013
Status verified
Aug 2019
Primary completion
Nov 23, 2015
Completion
Nov 23, 2015

Study Design

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

Arms

  • Experimental: Ranibizumab 0.5 mg monthly
    Monthly intravitreal injections of ranibizumab 0.5 mg in the core treatment period and PRN intravitreal injections of the same dose guided by best-corrected visual acuity (BCVA) stabilization in the extension treatment period
  • Experimental: Ranibizumab 0.5 mg pro re nata (PRN)
    PRN intravitreal injections of ranibizumab 0.5 mg guided by best-corrected visual acuity (BCVA) stabilization in the 23 month treatment period

Primary Outcome Measure

Average Change in Visual Acuity (Letters) From Month 3 to Month 4 Through Month 12 [ Time Frame: Month 3 to month 4 through Month 12 ]

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