Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD)

Macular Degeneration Clinical Trial

Official title:

24-month Randomized, Double-masked, Controlled, Multicenter, Phase II 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 AMD.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00433017
• Other study ID #: CBPD952A2309
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: February 8, 2007
• Last updated: April 18, 2011
• Start date: May 2007
• Est. completion date: July 2009

Study information

• Verified date: April 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Spain: Spanish Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesItaly: The Italian Medicines AgencyDenmark: Danish Medicines AgencyAustria: Federal Office for Safety in Health CareBelgium: The Federal Public Service (FPS) Health, Food Chain Safety and EnvironmentNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)Switzerland: SwissmedicPoland: Ministry of HealthHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity 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: Terminated
• Enrollment: 255
• Est. completion date: July 2009
• Est. primary completion date: July 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 choriodal neovascularization (CNV) due to age-related macular degeneration (AMD)

Exclusion Criteria:

• Choriodal 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 to the study eye, begun 15 minutes after the start of the infusion.
• Ranibizumab
Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection
• Placebo
As a placebo for verteporfin photodynamic therapy (for masking purposes), 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.

Locations

Country	Name	City	State
Austria	Novartis Investigative site	Wien
Belgium	Novartis Investigative site	Antwerpen
Denmark	Novartis Investigative site	Aalborg
France	Novartis Investigative site	Creteil
Germany	Novartis Investigative site	Regensburg
Hungary	Novartis Investigative site	Budapest
Italy	Novartis Investigative site	Firenze
Netherlands	Novartis Investigative site	Rotterdam
Poland	Novartis Investigative site	Warszawa
Spain	Novartis Investigative site	Madrid
Switzerland	Novartis Investigative site	Geneve
United Kingdom	Novartis Investigative site	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Best-corrected Visual Acuity (BCVA) 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 Participants 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 to Month 11	No
Secondary	Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12	The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).	Month 12	No
Secondary	Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12	Fluorescein angiography (FA) was used to assess the mean change of leakage of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less leakage.	Baseline and Month 12	No
Secondary	Mean Change in Central Retinal Thickness of the Study Eye at Month 12	Optical coherence tomography (OCT) was used to assess the mean change in retinal thickness of the study eye at the Central Reading Center (CRC). A negative change from baseline indicates improvement, ie, less thickness.	Baseline and Month 12	No