Clinical trial NCT00436553: Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Macular Degeneration
Choroidal Neovascularization
Keywords: Age-related macular degeneration; AMD
choroidal neovascularization
verteporfin
ranibizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 321
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12
timeFrame: Baseline and Month 12
measure: Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit
timeFrame: Month 2 up to Month 11
Secondary outcomes:
measure: Change From Baseline in Total Area of Leakage of the Study Eye at Month 12
timeFrame: Baseline and Month 12
measure: Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12
timeFrame: Month 12
measure: Change From Baseline in Central Retinal Thickness at Month 12
timeFrame: Baseline and Month 12
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Novartis Investigative Site
state: Arizona
city: Beverly Hills
country: United States
facility: Novartis Investigative Site
state: California
city: Oakland
country: United States
facility: Novartis Investigative Site
state: California
city: Pasadena
country: United States
facility: Novartis Investigative Site
state: California
city: Sacramento
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
country: United States
facility: West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130
state: California
city: Santa Ana
country: United States
facility: Novartis Investigative Site
state: California
city: Denver
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Aiea
country: United States
facility: Novartis Investigative Site
state: Hawaii
city: Iowa City
country: United States
facility: Novartis Investigative Site
state: Iowa
city: Wichita
country: United States
facility: Novartis Investigative Site
state: Kansas
city: Lexington
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Paducah
country: United States
facility: Novartis Investigative Site
state: Kentucky
city: Baltimore
country: United States
facility: Novartis Investigative Site
state: Maryland
city: Grand Rapids
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Royal Oak
country: United States
facility: Novartis Investigative SIte
state: Michigan
city: Williamsburg
country: United States
facility: Novartis Investigative Site
state: Michigan
city: Independence
country: United States
facility: Novartis Investigative Site
state: Missouri
city: St. Louis
country: United States
facility: Novartis Investigative Site
state: Missouri
city: Toms River
country: United States
facility: Novartis Investigative Site
state: New Jersey
city: Lynbrook
country: United States
facility: Novartis Investigative Site
state: New York
city: Rochester
country: United States
facility: Novartis Investigative Site
state: New York
city: Beachwood
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cincinnati
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Cleveland
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Pittsburgh
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: West Mifflin
country: United States
facility: Novartis Investigative Site
state: Pennsylvania
city: West Columbia
country: United States
facility: Novartis Investigative Site
state: South Carolina
city: Rapid City
country: United States
facility: Novartis Investigative Site
state: South Dakota
city: Kingsport
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Knoxville
country: United States
facility: Novartis Investigative Site
state: Tennessee
city: Austin
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Fairfax
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Novartis Investigative Site
state: Virginia
city: Milwaukee
country: United States
facility: Novartis Investigative Site
state: Wisconsin
city: Edmonton
country: Canada
facility: Novartis Investigative Site
state: Alberta
city: Vancouver
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Halifax
country: Canada
facility: Novartis Investigative Site
state: Nova Scotia
city: London
country: Canada
facility: Ivey Eye Institute, Dr. Thomas Sheidow
state: Ontario
city: London
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
citation: Kaiser PK, Boyer DS, Cruess AF, Slakter JS, Pilz S, Weisberger A; DENALI Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month results of the DENALI study. Ophthalmology. 2012 May;119(5):1001-10. doi: 10.1016/j.ophtha.2012.02.003. Epub 2012 Mar 22.