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

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

Sponsoren

Hauptsponsor: Genentech, Inc.

Quelle Genentech, Inc.
Kurze Zusammenfassung

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.

Gesamtstatus Completed
Anfangsdatum May 2003
Fertigstellungstermin September 2006
Phase Phase 3
Studientyp Interventional
Einschreibung 426
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: rhuFab V2 (ranibizumab)

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 50 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

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

Australia

Czech Republic

France

Germany

Hungary

United States

Überprüfungsdatum

March 2014

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Randomized

Hauptzweck: Treatment

Maskierung: Double

Quelle: ClinicalTrials.gov