Comparison of Age-related Macular Degeneration Treatments Trials: Lucentis-Avastin Trial
- Conditions
- Age Related Macular Degeneration
- Interventions
- Registration Number
- NCT00593450
- Lead Sponsor
- University of Pennsylvania
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1208
- Active, subfoveal choroidal neovascularization (CNV)
- Fibrosis < 50% of total lesion area
- Visual acuity (VA) 20/25-20/320
- Age ≥ 50 yrs
- At least 1 drusen (>63μ) in either eye or late AMD in fellow eye
- Previous treatment for CNV in study eye
- Other progressive retinal disease likely to compromise VA
- Contraindications to injections with Lucentis or Avastin
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 ranibizumab Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity. 1 ranibizumab Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing. 2 bevacizumab Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing. 4 bevacizumab Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
- Primary Outcome Measures
Name Time Method Change From Baseline in Visual-acuity Score (Continuous) 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.
- Secondary Outcome Measures
Name Time Method Number of Treatments 1 Year Cumulative over the 1 year of trial
Dye Leakage on Angiogram at 1 Year Change in Diastolic Blood Pressure From Baseline Baseline and 1 Year Area of Lesion Change From Baseline Baseline and 1 Year Visual-acuity Score and Snellen Equivalent (Frequency) at 1 Year Visual-acuity Score and Snellen Equivalent (Continuous) 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.Change From Baseline Visual-acuity Score (Frequency) Baseline and 1 Year Total Thickness Change From Baseline at Fovea Baseline and 1 Year Retinal Thickness Plus Subfoveal-fluid Thickness Change From Baseline at Fovea Baseline and 1 Year Fluid on Optical Coherence Tomography at 1 Year Average Cost of Drug/Patient at 1 Year Total Thickness at Fovea at 1 Year Area of Lesion at 1 Year Retinal Thickness Plus Subfoveal-fluid Thickness at Fovea at 1 Year Change in Systolic Blood Pressure From Baseline Baseline and 1 Year
Trial Locations
- Locations (51)
Retina Specialists
🇺🇸Towson, Maryland, United States
Ohio State University Eye Physicians & Surgeons-Retina Division
🇺🇸Dublin, Ohio, United States
Texas Retina Associates
🇺🇸Dallas, Texas, United States
Retina Associates of Cleveland
🇺🇸Beachwood, Ohio, United States
Vision Research Foundation/Associated Retinal Consultants, P.C.
🇺🇸Royal Oak, Michigan, United States
Retina Consultants of Arizona
🇺🇸Mesa, Arizona, United States
Massachusetts Eye & Ear Infirmary
🇺🇸Boston, Massachusetts, United States
Long Island Vitreoretinal Consultants
🇺🇸Riverhead, New York, United States
VitreoRetinal Surgery
🇺🇸Edina, Minnesota, United States
The Retina Group of Washington
🇺🇸Fairfax, Virginia, United States
Opthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Retina and Vitreous of Texas
🇺🇸Houston, Texas, United States
Barnes Retina Institute
🇺🇸Saint Louis, Missouri, United States
Retina Vitreous Center, PA
🇺🇸Toms River, New Jersey, United States
Retina Associates of Cleveland, Inc.
🇺🇸Lakewood, Ohio, United States
Southeastern Retina Associates
🇺🇸Knoxville, Tennessee, United States
Retina Vitreous Consultants
🇺🇸Pittsburgh, Pennsylvania, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Palmetto Retina Center
🇺🇸West Columbia, South Carolina, United States
Retina Associates Southwest, P.C.
🇺🇸Tucson, Arizona, United States
California Retina Consultants
🇺🇸Bakersfield, California, United States
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Harvard Vanguard Medical Associates
🇺🇸Boston, Massachusetts, United States
Retina Group of Florida
🇺🇸Fort Lauderdale, Florida, United States
Charlotte Eye, Ear, nose & Throat Associates
🇺🇸Charlotte, North Carolina, United States
Vision research Foundation/Associated Retinal Consultants. P.C.
🇺🇸Traverse City, Michigan, United States
Charlotte Eye,Ear, Nose & Throat Associates
🇺🇸Monroe, North Carolina, United States
Retina Diagnostic and Treatment Associates, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Vitreoretinal Consultants
🇺🇸Houston, Texas, United States
West Coast Retina Medical Group, Inc.
🇺🇸Walnut Creek, California, United States
California Retinal Consultants
🇺🇸Santa Barbara, California, United States
National Ophthalmic Research Institute
🇺🇸Fort Myers, Florida, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
Illinois Retina Associates
🇺🇸Joliet, Illinois, United States
Ingalls Memorial Hospital/Illinois Retina Associates
🇺🇸Harvey, Illinois, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Retina Associates of Kentucky
🇺🇸Lexington, Kentucky, United States
Elman Retina Group, P.A.
🇺🇸Baltimore, Maryland, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
University of California-Davis Medical Center
🇺🇸Sacramento, California, United States
Retinal Consultants Medical Group, Inc.
🇺🇸Sacramento, California, United States
Colorado Retina Associates
🇺🇸Denver, Colorado, United States
University of Louisville School of Medicine
🇺🇸Louisville, Kentucky, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Duke University Eye Center
🇺🇸Durham, North Carolina, United States
Dean A. McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Retina Northwest, P.C.
🇺🇸Portland, Oregon, United States
Casey Eye Institute
🇺🇸Portland, Oregon, United States
Retina Vitreous Associates, P.C.
🇺🇸Nashville, Tennessee, United States