A Study to Compare rhuFab V2 With Verteporfin Photodynamic in Treating Subfoveal Neovascular Macular Degeneration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT00061594
First received: May 29, 2003
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

This is a phase III, multicenter, randomized, double-masked, active treatment-controlled study of intravitreally administered ranibizumab compared with verteporfin (Visudyne) photodynamic therapy (PDT) in treating subfoveal neovascular mascular degeneration.


Condition Intervention Phase
Macular Degeneration
Drug: rhuFab V2 (ranibizumab)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double Masked, Active Treatment-Controlled Study of the Efficacy and Safety of rhuFab V2 (Ranibizumab) Compared With Verteporfin (Visudyne) Photodynamic Therapy in Subjects With Predominantly Classic Subfoveal Neovascular Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Genentech:

Estimated Enrollment: 426
Study Start Date: May 2003
Study Completion Date: September 2006
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • 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:

  • Prior treatment with verteporfin, external-beam radiation therapy, or transpupillary thermotherapy (TTT) in the study eye
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00061594

  Hide Study Locations
Locations
United States, Arizona
Retina Centers, P.C.
Tucson, Arizona, United States, 85704
University of Arizona
Tucson, Arizona, United States, 85711
United States, California
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States, 90211
UC Irvine
Irvine, California, United States, 92697
Doheny Eye Institute
Los Angeles, California, United States, 90033
California Vitreoretinal Research Center
Menlo Park, California, United States, 94025
No. California Retina-Vitreous Associates
Mountain View, California, United States, 94040
UCSF School of Medicine
San Francisco, California, United States, 94143
United States, Connecticut
Danbury Eye Physicians & Surgeons
Danbury, Connecticut, United States, 06810
New England Retina Associates
Hamden, Connecticut, United States, 06518
United States, Florida
Florida Retina Institute
Daytona Beach, Florida, United States, 32114
Retina Vitreous Consultants
Ft. Lauderdale, Florida, United States, 33334
Retina Health Center
Ft. Myers, Florida, United States, 33901
Retina Consultants of Southwest Florida
Ft. Myers, Florida, United States, 33901
Retina Associates of South Florida
Margate, Florida, United States, 33063
Bascom Palmer Eye Institute
Miami, Florida, United States, 33136
Central Florida Retina
Orlando, Florida, United States, 32806
Retina Care Specialists
Palm Beach Gardens, Florida, United States, 33410
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States, 33418
Ophthalmic Consultants
Sarasota, Florida, United States, 34239
Southern Vitreoretinal Associates PA
Tallahassee, Florida, United States, 32308
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Medical College of Georgia
Augusta, Georgia, United States, 30912
United States, Indiana
Thomas A. Ciulla, MD, PC
Indianapolis, Indiana, United States, 46280
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Maryland
Retina Associates PC
Annapolis, Maryland, United States, 21401
United States, Massachusetts
Center for Eye Research
Boston, Massachusetts, United States, 02114
New England Eye Center
Boston, Massachusetts, United States, 02111
New England Retina Consultants
West Springfield, Massachusetts, United States, 01089
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
Associated Retinal Consultants
Grand Rapids, Michigan, United States, 49546
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, United States, 48073
Retina Consultants of Michigan
Southfield, Michigan, United States, 48034
United States, Missouri
Retina Associates of St. Louis
Florissant, Missouri, United States, 63031
St. Louis University Eye Institute
St. Louis, Missouri, United States, 63104
United States, New Jersey
Delaware Valley Retina Associates
Lawrenceville, New Jersey, United States, 08648
United States, New York
Lions Eye Institute
Albany, New York, United States, 12208
Ophthalmic Consultants of Long Island
Rockville Centre, New York, United States, 11570
United States, North Carolina
Western Carolina Retinal Associates, PA
Asheville, North Carolina, United States, 28803
Southeast Clinical Research
Charlotte, North Carolina, United States, 28210
Duke Univ Medical Center/Duke Eye Center
Durham, North Carolina, United States, 22710
United States, Ohio
Retina Associates of Cleveland
Beachwood, Ohio, United States, 44122
Flavio Company
Cincinnati, Ohio, United States, 45242
Cleveland Clinic Foundation/Cole Eye Institute
Cleveland, Ohio, United States, 44195
Midwest Retina
Columbus, Ohio, United States, 43215
Retina Vitreous Associates
Toledo, Ohio, United States, 43608
United States, Oklahoma
Retinal Associates of Oklahoma
Oklahoma City, Oklahoma, United States, 73120
United States, Oregon
Retina & Vitreous Center of So. Oregon
Ashland, Oregon, United States, 97520
United States, Pennsylvania
Pennsylvania Retina Specialists
Camp Hill, Pennsylvania, United States, 17011
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, South Carolina
Retina Consultants of Charleston
Charleston, South Carolina, United States, 29414
Palmetto Retina Center
Columbia, South Carolina, United States, 29204
United States, South Dakota
BH Regional Eye Institute
Rapid City, South Dakota, United States, 57701
United States, Tennessee
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, United States, 37909
Retina Vitreous Associates
Nashville, Tennessee, United States, 37203
United States, Texas
Austin Retina Associates
Austin, Texas, United States, 78705
Brian Berger, MD P.A.
Austin, Texas, United States, 78705
Retina Specialists
Desoto, Texas, United States, 75115
UTMB
Galveston, Texas, United States, 77555
Vitreoretinal Consultants
Houston, Texas, United States, 77030
Valley Retina Institute, P.A.
McAllen, Texas, United States, 78503
Univ of Texas Health Science Center
San Antonio, Texas, United States, 78229
Medical Center Ophthalmology
San Antonio, Texas, United States, 78240
United States, Utah
John Moran Eye Center/Univ of Utah
Salt Lake City, Utah, United States, 84132
Rocky Mountain Retina Consultants
Salt Lake City, Utah, United States, 84107
United States, Virginia
Retina Group of Washington
Fairfax, Virginia, United States, 22031
United States, Washington
Vitreoretinal Associates
Seattle, Washington, United States, 98104
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia
University of Melbourne, Department of Ophthalmology
East Melbourne, Australia, VIC-3002
Marsden Eye Research Pty Ltd
Parramatta, Australia, NSW 2150
Save Sight Institute
Sydney, Australia, NSW-2000
Westmead Hospital
Westmead, Australia, NSW-2145
Czech Republic
Onci klinika FNKV
Praha 10, Czech Republic, 100 00
France
Clinique d'Ophtalmologie
Creteil Cedex, France, F-94010
Clinique Monticelli
Marseille, France, F-13008
Hôpital Lariboisière
Paris Cedex 10, France, F-75475
Germany
Universitätsklinikum Bonn
Bonn, Germany, D-53105
Universitatskliniken Koln
Koln, Germany, D-50924
Universitätsklinikum Leipzig
Leipzig, Germany, D-04103
Hungary
Semmelweis University, 1st Ophthalmological Department
Budapest, Hungary, H-1083
Sponsors and Collaborators
Genentech
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT00061594     History of Changes
Other Study ID Numbers: FVF2587g
Study First Received: May 29, 2003
Last Updated: March 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Neovascular age-related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014