Who is the sponsor?
Who are the patients?
Male or female over the age of fifty years with AMD The paticipating doctor will evaluate you to determine your eligibility into the study in accordance with the Study Eligibility and Exclusion Criteria.
How long are the eligible patients enrollment?
Assessments will be done monthly for a period of 24 months.
When did participation agreement start at our site?
July 17, 2003|
What is the enrollment goal for the sponsor?
Four hundred and twenty-six patients nation wide.
Is the enrollment still open?
No. This study is now closed.
What is this study investigating?
This is a Phase III, multicenter, randomized, double-masked, placo-controlled study. Designed to evaluate the safety and efficacy of LucentisTM (ranibizumab, rhuFAb V2) to significantly reduce the risk of vision loss. Patients will be assigned one of the following treatments: 1. PDT + Sham injection (placebo) 2. Sham PDT + LucentisTM Dose A 3. Sham PDT + LucentisTM Dose B This study will evaluate patients that have active, predominantly classic type wet AMD and compare those receiving LucentisTM (ranibizumab, rhuFAb V2) to those receiving just the PDT (VerteporfinTM Photodynamic laser Therapy) treatment.
How is the treatment administered?