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Sponsors and Collaborators: |
University Hospital Inselspital, Berne Novartis |
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Information provided by: | University Hospital Inselspital, Berne |
ClinicalTrials.gov Identifier: | NCT00413829 |
This study is an evaluation of the short term effects on CNV perfusion of a same-day administration of photodynamic therapy (PDT) with Visudyne® and an intravitreal injection of Lucentis® (ranibizumab, 0.3 mg). An evaluation of the short term effects on CNV perfusion of this combined treatment is needed for better understanding of treatment effects.
Condition | Intervention | Phase |
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Age Related Macular Degeneration |
Drug: Intravitreal ranibizumab with photodynamic therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Open-Label, Phase II Study Assessing Immediate Effects of Lucentis®(Ranibizumab) Administered in Conjunction With Photodynamic Therapy With Visudyne® in Patients With Choroidal Neovascularization Secondary to AMD |
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | March 2008 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
The primary objective is to quantify the short term effects on CNV perfusion of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab. These short term effects will be assessed with visual acuity measurements and ophthalmic examinations including indocyanine green (ICG) and fluorescein angiography (FA) as well as Optical Coherence Tomography (OCT) measurements. The primary variable for this assessment is the incidence of CNV closure one week after combined therapy as assessed with high speed ICG angiography. Fluorescein and ICG angiography will be performed using a scanning laser ophthalmoscope (HRA). All angiographic studies and OCT examinations will be evaluated by the Bern Photographic Reading Center in a masked fashion. Visual acuity assessments will be performed with Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts.
A secondary objective is to explore the effect of the same-day administration of photodynamic therapy with Visudyne® and an intravitreal injection of ranibizumab:
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Switzerland | |
Klinik und Poliklinik fuer Augenheilkunde, Inselspital | |
Bern, Switzerland |
Study Chair: | Sebastian Wolf, MD PhD | Klinik und Poliklinik fuer Augenheilkunde, Inselspital |
Principal Investigator: | Ute Wolf-Schnurrbusch, MD | Klinik und Polklinik fuer Augenheilkunde, Inselspital |
Responsible Party: | University Hospital Inselspital, Berne ( S. Wolf ) |
Study ID Numbers: | Aug1202 |
Study First Received: | December 19, 2006 |
Last Updated: | February 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00413829 |
Health Authority: | Switzerland: Swissmedic |
age related macular degeneration anti-VEGF therapy |
Metaplasia Eye Diseases Choroid Diseases Verteporfin Neoplasm Metastasis Retinal Degeneration |
Macular Degeneration Bevacizumab Neovascularization, Pathologic Retinal Diseases Retinal degeneration Choroidal Neovascularization |
Uveal Diseases Pathologic Processes |