A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration
NCT ID: NCT00061594
Last Updated: 2014-03-19
Study Results
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Basic Information
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COMPLETED
PHASE3
426 participants
INTERVENTIONAL
2003-05-31
2006-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
DOUBLE
Interventions
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rhuFab V2 (ranibizumab)
Eligibility Criteria
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Inclusion Criteria
* Age \>=50 years
* Eligibility for treatment with PDT using verteporfin in the study eye according to the Visudyne product labeling
* Future treatment with PDT using verteporfin anticipated or expected in the study eye
* Primary or recurrent subfoveal choroidal neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD) in the study eye
* A classic CNV component (well-demarcated hyperfluorescence boundaries in the early phase of the fluorescein angiogram) that is \>=50% of the total lesion size
* Total lesion size of less than or equal to 5400 um in greatest linear dimension (GLD)
* Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye
Exclusion Criteria
* Treatment with verteporfin in the non-study eye less than 7 days preceding Day 0
* Previous participation in a clinical trial (for either eye) involving anti angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)
* Previous intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Day 0
* History of vitrectomy surgery in the study eye
* History of submacular surgery or other surgical intervention for AMD in the study eye
* Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)
* Subretinal hemorrhage in the study eye that involves the center of the fovea, if the size of the hemorrhage is either \>=50% of the total lesion area or \>=1 disc area (DA) in size
* Subfoveal fibrosis or atrophy in the study eye
* CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
* Retinal pigment epithelial tear involving the macula in the study eye
* Any concurrent intraocular condition in the study eye (e.g., cataract or diabetic retinopathy) that, in the opinion of the Investigator could either: (1) Require medical or surgical intervention during the 24-month study period to prevent or treat visual loss that might result from that condition, or (2) If allowed to progress untreated, could likely contribute to loss of at least 2 Snellen equivalent lines of best corrected visual acuity over the 24-month study period
* Active intraocular inflammation (grade trace or above) in the study eye
* Current vitreous hemorrhage in the study eye
* History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
* History of idiopathic or autoimmune-associated uveitis in either eye
* Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
* Aphakia or absence of the posterior capsule in the study eye
* Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia
* Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding Day 0
* Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>=30 mmHg despite treatment with anti-glaucoma medication)
* History of glaucoma filtering surgery in the study eye
* History of corneal transplant in the study eye
* Premenopausal women not using adequate contraception
* History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications
* Current treatment for active systemic infection
* History of allergy to fluorescein, not amenable to treatment
* Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality to be analyzed and graded by the central reading center
* Inability to comply with study or follow up procedures
50 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Locations
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Retina Centers, P.C.
Tucson, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
UC Irvine
Irvine, California, United States
Doheny Eye Institute
Los Angeles, California, United States
California Vitreoretinal Research Center
Menlo Park, California, United States
No. California Retina-Vitreous Associates
Mountain View, California, United States
UCSF School of Medicine
San Francisco, California, United States
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States
New England Retina Associates
Hamden, Connecticut, United States
Florida Retina Institute
Daytona Beach, Florida, United States
Retina Vitreous Consultants
Fort Lauderdale, Florida, United States
Retina Consultants of Southwest Florida
Fort Myers, Florida, United States
Retina Health Center
Fort Myers, Florida, United States
Retina Associates of South Florida
Margate, Florida, United States
Bascom Palmer Eye Institute
Miami, Florida, United States
Central Florida Retina
Orlando, Florida, United States
Retina Care Specialists
Palm Beach Gardens, Florida, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States
Ophthalmic Consultants
Sarasota, Florida, United States
Southern Vitreoretinal Associates PA
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Thomas A. Ciulla, MD, PC
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Retina Associates PC
Annapolis, Maryland, United States
New England Eye Center
Boston, Massachusetts, United States
Center for Eye Research
Boston, Massachusetts, United States
New England Retina Consultants
West Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Associated Retinal Consultants
Grand Rapids, Michigan, United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States
Retina Consultants of Michigan
Southfield, Michigan, United States
Retina Associates of St. Louis
Florissant, Missouri, United States
St. Louis University Eye Institute
St Louis, Missouri, United States
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States
Lions Eye Institute
Albany, New York, United States
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States
Western Carolina Retinal Associates, PA
Asheville, North Carolina, United States
Southeast Clinical Research
Charlotte, North Carolina, United States
Duke Univ Medical Center/Duke Eye Center
Durham, North Carolina, United States
Retina Associates of Cleveland
Beachwood, Ohio, United States
Flavio Company
Cincinnati, Ohio, United States
Cleveland Clinic Foundation/Cole Eye Institute
Cleveland, Ohio, United States
Midwest Retina
Columbus, Ohio, United States
Retina Vitreous Associates
Toledo, Ohio, United States
Retinal Associates of Oklahoma
Oklahoma City, Oklahoma, United States
Retina & Vitreous Center of So. Oregon
Ashland, Oregon, United States
Pennsylvania Retina Specialists
Camp Hill, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Retina Consultants of Charleston
Charleston, South Carolina, United States
Palmetto Retina Center
Columbia, South Carolina, United States
BH Regional Eye Institute
Rapid City, South Dakota, United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States
Retina Vitreous Associates
Nashville, Tennessee, United States
Austin Retina Associates
Austin, Texas, United States
Brian Berger, MD P.A.
Austin, Texas, United States
Retina Specialists
DeSoto, Texas, United States
UTMB
Galveston, Texas, United States
Vitreoretinal Consultants
Houston, Texas, United States
Valley Retina Institute, P.A.
McAllen, Texas, United States
Univ of Texas Health Science Center
San Antonio, Texas, United States
Medical Center Ophthalmology
San Antonio, Texas, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States
John Moran Eye Center/Univ of Utah
Salt Lake City, Utah, United States
Retina Group of Washington
Fairfax, Virginia, United States
Vitreoretinal Associates
Seattle, Washington, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
University of Melbourne, Department of Ophthalmology
East Melbourne, , Australia
Marsden Eye Research Pty Ltd
Parramatta, , Australia
Save Sight Institute
Sydney, , Australia
Westmead Hospital
Westmead, , Australia
Onci klinika FNKV
Prague, , Czechia
Clinique d'Ophtalmologie
Créteil, , France
Clinique Monticelli
Marseille, , France
Hôpital Lariboisière
Paris, , France
Universitätsklinikum Bonn
Bonn, , Germany
Universitatskliniken Koln
Cologne, , Germany
Universitätsklinikum Leipzig
Leipzig, , Germany
Semmelweis University, 1st Ophthalmological Department
Budapest, , Hungary
Countries
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References
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Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.
Kaiser PK, Brown DM, Zhang K, Hudson HL, Holz FG, Shapiro H, Schneider S, Acharya NR. Ranibizumab for predominantly classic neovascular age-related macular degeneration: subgroup analysis of first-year ANCHOR results. Am J Ophthalmol. 2007 Dec;144(6):850-857. doi: 10.1016/j.ajo.2007.08.012. Epub 2007 Oct 22.
Brown DM, Michels M, Kaiser PK, Heier JS, Sy JP, Ianchulev T; ANCHOR Study Group. Ranibizumab versus verteporfin photodynamic therapy for neovascular age-related macular degeneration: Two-year results of the ANCHOR study. Ophthalmology. 2009 Jan;116(1):57-65.e5. doi: 10.1016/j.ophtha.2008.10.018.
Suner IJ, Kokame GT, Yu E, Ward J, Dolan C, Bressler NM. Responsiveness of NEI VFQ-25 to changes in visual acuity in neovascular AMD: validation studies from two phase 3 clinical trials. Invest Ophthalmol Vis Sci. 2009 Aug;50(8):3629-35. doi: 10.1167/iovs.08-3225. Epub 2009 Feb 28.
Bressler NM, Chang TS, Fine JT, Dolan CM, Ward J; Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration (ANCHOR) Research Group. Improved vision-related function after ranibizumab vs photodynamic therapy: a randomized clinical trial. Arch Ophthalmol. 2009 Jan;127(1):13-21. doi: 10.1001/archophthalmol.2008.562.
Thach AB, Yau L, Hoang C, Tuomi L. Time to clinically significant visual acuity gains after ranibizumab treatment for retinal vein occlusion: BRAVO and CRUISE trials. Ophthalmology. 2014 May;121(5):1059-66. doi: 10.1016/j.ophtha.2013.11.022. Epub 2014 Jan 11.
Weinberg DV, Shapiro H, Ehrlich JS. Ranibizumab treatment outcomes in phakic versus pseudophakic eyes: an individual patient data analysis of 2 phase 3 trials. Ophthalmology. 2013 Jun;120(6):1278-82. doi: 10.1016/j.ophtha.2012.11.042. Epub 2013 Feb 28.
Bressler NM, Chang TS, Varma R, Suner I, Lee P, Dolan CM, Ward J, Ianchulev T, Fine J. Driving ability reported by neovascular age-related macular degeneration patients after treatment with ranibizumab. Ophthalmology. 2013 Jan;120(1):160-8. doi: 10.1016/j.ophtha.2012.07.027. Epub 2012 Sep 23.
Rosenfeld PJ, Shapiro H, Ehrlich JS, Wong P; MARINA and ANCHOR Study Groups. Cataract surgery in ranibizumab-treated patients with neovascular age-related macular degeneration from the phase 3 ANCHOR and MARINA trials. Am J Ophthalmol. 2011 Nov;152(5):793-8. doi: 10.1016/j.ajo.2011.04.025. Epub 2011 Jul 26.
Rosenfeld PJ, Shapiro H, Tuomi L, Webster M, Elledge J, Blodi B; MARINA and ANCHOR Study Groups. Characteristics of patients losing vision after 2 years of monthly dosing in the phase III ranibizumab clinical trials. Ophthalmology. 2011 Mar;118(3):523-30. doi: 10.1016/j.ophtha.2010.07.011.
Barbazetto IA, Saroj N, Shapiro H, Wong P, Ho AC, Freund KB. Incidence of new choroidal neovascularization in fellow eyes of patients treated in the MARINA and ANCHOR trials. Am J Ophthalmol. 2010 Jun;149(6):939-946.e1. doi: 10.1016/j.ajo.2010.01.007. Epub 2010 Apr 8.
Bressler NM, Chang TS, Suner IJ, Fine JT, Dolan CM, Ward J, Ianchulev T; MARINA and ANCHOR Research Groups. Vision-related function after ranibizumab treatment by better- or worse-seeing eye: clinical trial results from MARINA and ANCHOR. Ophthalmology. 2010 Apr;117(4):747-56.e4. doi: 10.1016/j.ophtha.2009.09.002. Epub 2010 Mar 2.
Other Identifiers
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FVF2587g
Identifier Type: -
Identifier Source: org_study_id
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