SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Sponsor
Novartis
Study ID
NCT00331864
Phase
PHASE3
Status
Completed

Conditions

  • Age Related Macular Degeneration
  • Choroidal Neovascularization

Eligibility Criteria

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

Interventions

Study Details

Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Key Dates

First listed
May 31, 2006
Start date
Apr 30, 2006
Status verified
Feb 2011
Primary completion
Apr 30, 2008
Completion
Apr 30, 2008

Study Design

Enrollment
531 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
    Ranibizumab-naïve (Non-ANCHOR) patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on re-treatment criteria described in the protocol. For patients who had participated in the ANCHOR study, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met re-treatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.

Primary Outcome Measure

Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye [ Time Frame: Baseline through end of study (12 month treatment period) ]

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