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

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061594
• Other study ID #: FVF2587g
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2003
• Last updated: March 18, 2014
• Start date: May 2003
• Est. completion date: September 2006

Study information

• Verified date: March 2014
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 426
• Est. completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• rhuFab V2 (ranibizumab)

Locations

Country	Name	City	State
Australia	University of Melbourne, Department of Ophthalmology	East Melbourne
Australia	Marsden Eye Research Pty Ltd	Parramatta
Australia	Save Sight Institute	Sydney
Australia	Westmead Hospital	Westmead
Czech Republic	Onci klinika FNKV	Praha 10
France	Clinique d'Ophtalmologie	Creteil Cedex
France	Clinique Monticelli	Marseille
France	Hôpital Lariboisière	Paris Cedex 10
Germany	Universitätsklinikum Bonn	Bonn
Germany	Universitatskliniken Koln	Koln
Germany	Universitätsklinikum Leipzig	Leipzig
Hungary	Semmelweis University, 1st Ophthalmological Department	Budapest
United States	Lions Eye Institute	Albany	New York
United States	University of Michigan	Ann Arbor	Michigan
United States	Retina Associates PC	Annapolis	Maryland
United States	Western Carolina Retinal Associates, PA	Asheville	North Carolina
United States	Retina & Vitreous Center of So. Oregon	Ashland	Oregon
United States	Emory University	Atlanta	Georgia
United States	Medical College of Georgia	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	Brian Berger, MD P.A.	Austin	Texas
United States	Retina Associates of Cleveland	Beachwood	Ohio
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Center for Eye Research	Boston	Massachusetts
United States	New England Eye Center	Boston	Massachusetts
United States	Pennsylvania Retina Specialists	Camp Hill	Pennsylvania
United States	Retina Consultants of Charleston	Charleston	South Carolina
United States	Southeast Clinical Research	Charlotte	North Carolina
United States	Flavio Company	Cincinnati	Ohio
United States	Cleveland Clinic Foundation/Cole Eye Institute	Cleveland	Ohio
United States	Palmetto Retina Center	Columbia	South Carolina
United States	Midwest Retina	Columbus	Ohio
United States	Danbury Eye Physicians & Surgeons	Danbury	Connecticut
United States	Florida Retina Institute	Daytona Beach	Florida
United States	Retina Specialists	Desoto	Texas
United States	Duke Univ Medical Center/Duke Eye Center	Durham	North Carolina
United States	Retina Group of Washington	Fairfax	Virginia
United States	Retina Associates of St. Louis	Florissant	Missouri
United States	Retina Vitreous Consultants	Ft. Lauderdale	Florida
United States	Retina Consultants of Southwest Florida	Ft. Myers	Florida
United States	Retina Health Center	Ft. Myers	Florida
United States	UTMB	Galveston	Texas
United States	Associated Retinal Consultants	Grand Rapids	Michigan
United States	New England Retina Associates	Hamden	Connecticut
United States	Vitreoretinal Consultants	Houston	Texas
United States	Thomas A. Ciulla, MD, PC	Indianapolis	Indiana
United States	UC Irvine	Irvine	California
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Southeastern Retina Associates, P.C.	Knoxville	Tennessee
United States	Delaware Valley Retina Associates	Lawrenceville	New Jersey
United States	Doheny Eye Institute	Los Angeles	California
United States	Retina Associates of South Florida	Margate	Florida
United States	Valley Retina Institute, P.A.	McAllen	Texas
United States	California Vitreoretinal Research Center	Menlo Park	California
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	No. California Retina-Vitreous Associates	Mountain View	California
United States	Retina Vitreous Associates	Nashville	Tennessee
United States	Retinal Associates of Oklahoma	Oklahoma City	Oklahoma
United States	Central Florida Retina	Orlando	Florida
United States	Bascom Palmer Eye Institute	Palm Beach Gardens	Florida
United States	Retina Care Specialists	Palm Beach Gardens	Florida
United States	Wills Eye Hospital	Philadelphia	Pennsylvania
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	BH Regional Eye Institute	Rapid City	South Dakota
United States	Ophthalmic Consultants of Long Island	Rockville Centre	New York
United States	Associated Retinal Consultants, P.C.	Royal Oak	Michigan
United States	John Moran Eye Center/Univ of Utah	Salt Lake City	Utah
United States	Rocky Mountain Retina Consultants	Salt Lake City	Utah
United States	Medical Center Ophthalmology	San Antonio	Texas
United States	Univ of Texas Health Science Center	San Antonio	Texas
United States	UCSF School of Medicine	San Francisco	California
United States	Ophthalmic Consultants	Sarasota	Florida
United States	Vitreoretinal Associates	Seattle	Washington
United States	Retina Consultants of Michigan	Southfield	Michigan
United States	St. Louis University Eye Institute	St. Louis	Missouri
United States	Southern Vitreoretinal Associates PA	Tallahassee	Florida
United States	University of South Florida	Tampa	Florida
United States	Retina Vitreous Associates	Toledo	Ohio
United States	Retina Centers, P.C.	Tucson	Arizona
United States	University of Arizona	Tucson	Arizona
United States	New England Retina Consultants	West Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Czech Republic,  France,  Germany,  Hungary, 

References & Publications (5)

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 — View Citation

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. — View Citation

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 — View Citation

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- — View Citation

Suñer 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 — View Citation