Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
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ClinicalTrials.gov Identifier: NCT00429962 |
Recruitment Status
:
Completed
First Posted
: February 1, 2007
Last Update Posted
: April 7, 2009
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Sponsor:
University Hospital, Basel, Switzerland
Information provided by:
University Hospital, Basel, Switzerland
Tracking Information | ||||
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First Submitted Date ICMJE | January 31, 2007 | |||
First Posted Date ICMJE | February 1, 2007 | |||
Last Update Posted Date | April 7, 2009 | |||
Study Start Date ICMJE | July 2006 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
First injection with PDT [ Time Frame: monthly ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | Complete list of historical versions of study NCT00429962 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections [ Time Frame: monthly ] | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV | |||
Official Title ICMJE | Randomized, Phase IIIb Study Comparing Safety, Tolerability and Efficacy Between Lucentis® Administered in Conjunction With PDT With Visudyne® and Lucentis® in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration | |||
Brief Summary | This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD | |||
Detailed Description | Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD. However, the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly formed vessels. The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintaining/improving the increase in vision improvement observed with ranibizumab monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date | June 2008 | |||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 50 Years to 95 Years (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Switzerland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00429962 | |||
Other Study ID Numbers ICMJE | 081-PRC-2006-005 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Selim Orgul, University Hospital, Basel, Switzerland | |||
Study Sponsor ICMJE | University Hospital, Basel, Switzerland | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | University Hospital, Basel, Switzerland | |||
Verification Date | April 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |