ranibizumab
Drug- 0.5 mg (0.05 mL)intravitreal injection
Other names: Lucentis
NCT Number: NCT00593450
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.
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Notify Me50 year and older
All sexes
Interventional
Phase 3
Retina Consultants of Arizona, Mesa, Arizona, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: Lucentis
Other names: Avastin
Time frame: Baseline and 1 Year
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
Time frame: at 1 Year
Time frame: at 1 Year
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: 1 Year
Cumulative over the 1 year of trial
Time frame: at 1 Year
Time frame: at 1 Year
Time frame: Baseline and 1 Year
Time frame: at 1 Year
Time frame: Baseline and 1 Year
Time frame: at 1 Year
Time frame: at 1 Year
Time frame: at 1 Year
Time frame: Baseline and 1 Year
Time frame: Baseline and 1 Year
Time frame: Baseline and 1 Year
University of Pennsylvania
Other
Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial (CATT)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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