Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

Macular Degeneration Clinical Trial

Official title:

A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00436553
• Other study ID #: CBPD952A2308
• Status: Completed
• Phase: Phase 3
• First received: February 16, 2007
• Last updated: March 23, 2011
• Start date: February 2007
• Est. completion date: October 2009

Study information

• Verified date: March 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 321
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subjects of either gender age 50 years or older

• Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)

Exclusion Criteria:

• Choroidal neovascularization due to causes other than AMD

• Prior treatment for neovascular AMD in the study eye

Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• Verteporfin Photodynamic Therapy
After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 (Standard Fluence rate) or 25 J/cm^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.
• Ranibizumab
Ranibizumab 0.5 mg administered as an intravitreal injection.
• Verteporfin Placebo
To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.
• Ranibizumab Placebo
To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.

Locations

Country	Name	City	State
Canada	Novartis Investigative Site	Edmonton	Alberta
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Ivey Eye Institute, Dr. Thomas Sheidow	London	Ontario
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
United States	Novartis Investigative Site	Aiea	Hawaii
United States	Novartis Investigative Site	Austin	Texas
United States	Novartis Investigative Site	Baltimore	Maryland
United States	Novartis Investigative Site	Beachwood	Ohio
United States	Novartis Investigative Site	Beverly Hills	California
United States	Novartis Investigative Site	Cincinnati	Ohio
United States	Novartis Investigative Site	Cleveland	Ohio
United States	Novartis Investigative Site	Denver	Colorado
United States	Novartis Investigative Site	Fairfax	Virginia
United States	Novartis Investigative Site	Grand Rapids	Michigan
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Independence	Missouri
United States	Novartis Investigative Site	Iowa City	Iowa
United States	Novartis Investigative Site	Kingsport	Tennessee
United States	Novartis Investigative Site	Knoxville	Tennessee
United States	Novartis Investigative Site	Lexington	Kentucky
United States	Novartis Investigative Site	Lynbrook	New York
United States	Novartis Investigative Site	Milwaukee	Wisconsin
United States	Novartis Investigative Site	Oakland	California
United States	Novartis Investigative Site	Paducah	Kentucky
United States	Novartis Investigative Site	Pasadena	California
United States	Novartis Investigative Site	Pittsburgh	Pennsylvania
United States	Novartis Investigative Site	Rapid City	South Dakota
United States	Novartis Investigative Site	Richmond	Virginia
United States	Novartis Investigative Site	Rochester	New York
United States	Novartis Investigative SIte	Royal Oak	Michigan
United States	Novartis Investigative Site	Sacramento	California
United States	West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130	San Francisco	California
United States	Novartis Investigative Site	Santa Ana	California
United States	Novartis Investigative Site	St. Louis	Missouri
United States	Novartis Investigative Site	Toms River	New Jersey
United States	Novartis Investigative Site	Tucson	Arizona
United States	Novartis Investigative Site	West Columbia	South Carolina
United States	Novartis Investigative Site	West Mifflin	Pennsylvania
United States	Novartis Investigative Site	Wichita	Kansas
United States	Novartis Investigative Site	Williamsburg	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12	BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.	Baseline and Month 12	No
Primary	Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit	The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.	Month 2 up to Month 11	No
Secondary	Change From Baseline in Total Area of Leakage of the Study Eye at Month 12	Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).	Baseline and Month 12	No
Secondary	Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).	Month 12	No
Secondary	Change From Baseline in Central Retinal Thickness at Month 12	Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.	Baseline and Month 12	No