Efficacy and Safety of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Sponsor
Novartis
Study ID
NCT00275821
Phase
PHASE3
Status
Completed

Conditions

  • Age Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Ranibizumab 0.3 mg - 3 times monthly, then quarterly — DRUG
    Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
  • Ranibizumab 0.5 mg - 3 times monthly, then quarterly — DRUG
    Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
  • Ranibizumab 0.3 mg monthly — DRUG
    Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.

Study Details

The study will test if the efficacy and safety of an alternative dosing regimen is as effective as monthly injections.

Key Dates

First listed
Jan 12, 2006
Start date
Dec 31, 2005
Status verified
Feb 2011
Primary completion
Jan 31, 2008
Completion
Jan 31, 2008

Study Design

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

Arms

  • Experimental: Ranibizumab 0.3 mg - 3 times monthly, then quarterly
  • Experimental: Ranibizumab 0.5 mg - 3 times monthly, then quarterly
  • Active Comparator: Ranibizumab 0.3 mg monthly

Primary Outcome Measure

Mean Change From Baseline in Best-corrected Visual Acuity of the Study Eye at Month 12 [ Time Frame: Baseline to Month 12 ]

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