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

March 18, 2014 updated by: Genentech, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

426

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genentech, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2003

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

May 29, 2003

First Submitted That Met QC Criteria

May 29, 2003

First Posted (Estimate)

May 30, 2003

Study Record Updates

Last Update Posted (Estimate)

March 19, 2014

Last Update Submitted That Met QC Criteria

March 18, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FVF2587g

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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