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

This study has been terminated.
(Study was terminated based on the results of analyses performed as planned at Month 12.)
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00433017
First received: February 8, 2007
Last updated: April 18, 2011
Last verified: April 2011
  Purpose

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


Condition Intervention Phase
Macular Degeneration
Choroidal Neovascularization
Drug: Verteporfin Photodynamic Therapy
Drug: Ranibizumab
Drug: Placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12. [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.

  • Percent of Participants With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit [ Time Frame: Month 2 to Month 11 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    The proportion of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).

  • Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Change in Central Retinal Thickness of the Study Eye at Month 12 [ Time Frame: Baseline and Month 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 255
Study Start Date: May 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Verteporfin + Ranibizumab
Verteporfin (6 mg/m^2) photodynamic therapy (PDT) and ranibizumab (0.5 mg). Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
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.
Other Name: Visudyne
Drug: Ranibizumab
Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection
Other Name: Lucentis
Active Comparator: Ranibizumab Monotherapy
Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
Drug: Ranibizumab
Ranibizumab 0.5 mg (0.05 mL of 10 mg/mL solution for injection) administered as an intravitreal injection
Other Name: Lucentis
Drug: 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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433017

Locations
Austria
Novartis Investigative site
Wien, Austria
Belgium
Novartis Investigative site
Antwerpen, Belgium
Denmark
Novartis Investigative site
Aalborg, Denmark
France
Novartis Investigative site
Creteil, France
Germany
Novartis Investigative site
Regensburg, Germany
Hungary
Novartis Investigative site
Budapest, Hungary
Italy
Novartis Investigative site
Firenze, Italy
Netherlands
Novartis Investigative site
Rotterdam, Netherlands
Poland
Novartis Investigative site
Warszawa, Poland
Spain
Novartis Investigative site
Madrid, Spain
Switzerland
Novartis Investigative site
Geneve, Switzerland
United Kingdom
Novartis Investigative site
Manchester, United Kingdom
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Novartis
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00433017     History of Changes
Other Study ID Numbers: CBPD952A2309
Study First Received: February 8, 2007
Results First Received: January 12, 2011
Last Updated: April 18, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Italy: The Italian Medicines Agency
Denmark: Danish Medicines Agency
Austria: Federal Office for Safety in Health Care
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Switzerland: Swissmedic
Poland: Ministry of Health
Hungary: National Institute of Pharmacy

Keywords provided by Novartis:
Age-related macular degeneration
AMD
Choroidal neovascularization
Verteporfin
Ranibizumab

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 15, 2014