The purpose of the study is to evaluate the relative efficacy and safety of treatment of neovascular AMD with Lucentis on a fixed schedule, Avastin on a fixed schedule, Lucentis on a variable schedule, and Avastin on a variable schedule. A five year follow-up visit is being conducted in 2014 to gather information on long term outcomes.
Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other Western countries. More than 1.6 million people in the US currently have one or both eyes affected by the advanced stage of AMD. Lucentis® is the most effective treatment for neovascular AMD studied to date. Bevacizumab (Avastin®) and Lucentis® are derived from the same monoclonal antibody. Following the encouraging clinical trial results with Lucentis®, several investigators began evaluating intravitreal Avastin® for the treatment of CNV. Given its molecular similarity to Lucentis, its low cost, and its availability, the interest in Avastin® has been considerable. Avastin® has not been evaluated relative to Lucentis®. In addition, previous studies do not answer the question of whether a reduced dosing schedule is as effective as a fixed schedule of monthly injections. Treatment dependent on clinical response has the potential to reduce the treatment burden to patients as well as to reduce the overall cost of therapy. Only a single eye in each patient was analyzed. At the five year follow-up visit, the subjects will undergo the same examinations and procedures as in the original study; however, the five year follow-up visit deos not involve any study treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,208
• 0.5 mg (0.05 mL)intravitreal injection
• 1.25 mg (0.05 mL)intravitreal injection
Change From Baseline in Visual-acuity Score (Continuous)
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. The VA score change is the difference of the VA score at 1 Year and the VA score at baseline. In this study, the outcome VA score change is ranged from -71 to 52, with the higher VA score change the better visual acuity improvement.
Time frame: Baseline and 1 Year
Change From Baseline Visual-acuity Score (Frequency)
Time frame: Baseline and 1 Year
Visual-acuity Score and Snellen Equivalent (Frequency)
Time frame: at 1 Year
Visual-acuity Score and Snellen Equivalent (Continuous)
Visual acuity testing was performed with the Electronic Visual Tester (EVA) following the ETDRS protocol. VA score is measured as number of letters read correctly. In this study, the outcome VA score is ranged from 0 to 97, with the higher score the better visual acuity.
Time frame: at 1 Year
Number of Treatments
Cumulative over the 1 year of trial
Time frame: 1 Year
Average Cost of Drug/Patient
Time frame: at 1 Year
Total Thickness at Fovea
Time frame: at 1 Year
Total Thickness Change From Baseline at Fovea
Time frame: Baseline and 1 Year
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Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea
Time frame: at 1 Year
Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea
Time frame: Baseline and 1 Year
Fluid on Optical Coherence Tomography
Time frame: at 1 Year
Dye Leakage on Angiogram
Time frame: at 1 Year
Area of Lesion
Time frame: at 1 Year
Area of Lesion Change From Baseline
Time frame: Baseline and 1 Year
Change in Systolic Blood Pressure From Baseline
Time frame: Baseline and 1 Year
Change in Diastolic Blood Pressure From Baseline
Time frame: Baseline and 1 Year