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

PHASE3CompletedINTERVENTIONAL
Enrollment

321

Participants

Timeline

Start Date

February 28, 2007

Primary Completion Date

October 31, 2009

Study Completion Date

October 31, 2009

Conditions
Macular DegenerationChoroidal Neovascularization
Interventions
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.

DRUG

Ranibizumab

Ranibizumab 0.5 mg administered as an intravitreal injection.

DRUG

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.

DRUG

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.

Trial Locations (43)

11563

Novartis Investigative Site, Lynbrook

14620

Novartis Investigative Site, Rochester

15122

Novartis Investigative Site, West Mifflin

15213

Novartis Investigative Site, Pittsburgh

21205

Novartis Investigative Site, Baltimore

22031

Novartis Investigative Site, Fairfax

23226

Novartis Investigative Site, Richmond

29169

Novartis Investigative Site, West Columbia

37660

Novartis Investigative Site, Kingsport

37909

Novartis Investigative Site, Knoxville

40509

Novartis Investigative Site, Lexington

42001

Novartis Investigative Site, Paducah

44122

Novartis Investigative Site, Beachwood

44195

Novartis Investigative Site, Cleveland

45242

Novartis Investigative Site, Cincinnati

48073

Novartis Investigative SIte, Royal Oak

49252

Novartis Investigative Site, Grand Rapids

49690

Novartis Investigative Site, Williamsburg

52242

Novartis Investigative Site, Iowa City

53226

Novartis Investigative Site, Milwaukee

57701

Novartis Investigative Site, Rapid City

63110

Novartis Investigative Site, St Louis

64055

Novartis Investigative Site, Independence

67214

Novartis Investigative Site, Wichita

77030

Novartis Investigative Site, Houston

78705

Novartis Investigative Site, Austin

80210

Novartis Investigative Site, Denver

85704

Novartis Investigative Site, Tucson

90211

Novartis Investigative Site, Beverly Hills

92705

Novartis Investigative Site, Santa Ana

94107

West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130, San Francisco

94609

Novartis Investigative Site, Oakland

95819

Novartis Investigative Site, Sacramento

96701

Novartis Investigative Site, ‘Aiea

91105-3153

Novartis Investigative Site, Pasadena

08755

Novartis Investigative Site, Toms River

T5H OX5

Novartis Investigative Site, Edmonton

V5Z 3N9

Novartis Investigative Site, Vancouver

B3H 2Y6

Novartis Investigative Site, Halifax

N6A 4G5

Ivey Eye Institute, Dr. Thomas Sheidow, London

Novartis Investigative Site, London

KIH 8L6

Novartis Investigative Site, Ottawa

H2L 4MI

Novartis Investigative Site, Montreal

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis

INDUSTRY