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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
History of Changes
Results First Received: January 12, 2011  
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
Conditions: Macular Degeneration
Choroidal Neovascularization
Interventions: Drug: Verteporfin Photodynamic Therapy
Drug: Ranibizumab
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Verteporfin + Ranibizumab 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).
Ranibizumab 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).

Participant Flow:   Overall Study
    Verteporfin + Ranibizumab     Ranibizumab  
STARTED     122     133  
Completed 12 Month Phase     114     126  
COMPLETED     26     32  
NOT COMPLETED     96     101  
Adverse Event                 5                 3  
Withdrawal by Subject                 4                 5  
Lost to Follow-up                 3                 4  
Administrative problems                 80                 86  
Protocol Violation                 1                 0  
Death                 2                 2  
Subject no longer requires study drug                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Verteporfin + Ranibizumab 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).
Ranibizumab 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).
Total Total of all reporting groups

Baseline Measures
    Verteporfin + Ranibizumab     Ranibizumab     Total  
Number of Participants  
[units: participants]
 		  122     133     255  
Age  
[units: years]
Mean ± Standard Deviation 		  76.8  ± 7.65     75.5  ± 7.44     76.1  ± 7.55  
Gender  
[units: participants]
 		     
Female     78     74     152  
Male     44     59     103  



  Outcome Measures
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1.  Primary:   Change From Baseline in Best-corrected Visual Acuity (BCVA) at Month 12.   [ Time Frame: Baseline and Month 12 ]
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2.  Primary:   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 ]
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3.  Secondary:   Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12   [ Time Frame: Month 12 ]
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4.  Secondary:   Mean Change in Total Area of Leakage (Observed) of the Study Eye at Month 12   [ Time Frame: Baseline and Month 12 ]
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5.  Secondary:   Mean Change in Central Retinal Thickness of the Study Eye at Month 12   [ Time Frame: Baseline and Month 12 ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


No publications provided by Novartis

Publications automatically indexed to this study:


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