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Sponsored by: |
University Hospital, Basel, Switzerland |
Information provided by: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00429962 |
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
Condition | Intervention | Phase |
Choroidal Neovascularization Age-Related Macular Degeneration |
Drug: intravitreal ranibizumab Drug: intravitreal ranibizumab & photodynamic therapy |
Phase III |
Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
MedlinePlus related topics: | Macular Degeneration |
ChemIDplus related topics: | Ranibizumab Verteporfin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Enrollment: | 40 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
intravitreal ranibizumab used in combination with verteporfin photodynamic therapy
|
Drug: intravitreal ranibizumab & photodynamic therapy
intraocular injection photodynamic treatment (LASER) after intravenous injection
|
B: Active Comparator
intravitreal ranibizumab
|
Drug: intravitreal ranibizumab
intraocular injection
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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
Ages Eligible for Study: | 50 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
patients over 50 years, subfoveal CNV of any type secondary to age-related macular degeneration (AMD), no "macula-treatment for the last 30 days (e.g. with PDT, TA, Laser, Macugen®).
Occult CNV:
Exclusion Criteria:
Switzerland, Basel-Stadt | |||||
University Eye Clinic | |||||
Basel, Basel-Stadt, Switzerland, 4031 |
University Hospital, Basel, Switzerland |
Study Director: | Ulrike Schneider, MD | University Eye Clinic Basel |
Responsible Party: | University Hospital, Basel, Switzerland ( Selim Orgul ) |
Study ID Numbers: | 081-PRC-2006-005 |
First Received: | January 31, 2007 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00429962 |
Health Authority: | Switzerland: Swissmedic |
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