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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00709657 |
Age related macula degeneration is one of the most common sight threatening diseases of the elderly. The so called wet form of AMD is caused by choroidal neovascularisation (CNV) of pathological vessels, which lead to leakage, bleeding and macular edema. Several lines of evidence suggest that vascular endothelial growth factor (VEGF) plays a key role in the induction CNV. Recent evidence indicates that overexpression of VEGF in the retinal pigment epithelium may lead to the development of CNV in experimental models, and intravitreal injection of a VEGF blocker prevents the development of experimental CNV. This hypothesis is also supported by the promising effects of anti-VEGF treatment in patients with choroidal neovascularisation. The substances currently in clinical use include ranibizumab (Lucentis®), bevacizumab (Avastin®) and pegaptanib (Macugen®).
However, from a physiological point of view, VEGF also serves as a survival factor for existing vessels and for neuronal cells. Moreover, it has been reported that VEGF induces vasodilatation, most probably by an increased production of nitric oxide. Accordingly one may hypothesize that anti-VEGF treatment is associated with ocular vasoconstriction with unknown long term results. Thus, in the current study, the investigators set out to investigate whether the ocular perfusion is affected by a single intravitreal anti-VEGF.
Condition | Intervention |
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Macular Degeneration Regional Blood Flow Vascular Endothelial Growth Factor |
Drug: ranibizumab, bevacizumab or pegaptanib |
Study Type: | Interventional |
Study Design: | Basic Science, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Effect of a Single Intravitreal Anti-VEGF Therapy on Optic Nerve Head Perfusion |
Estimated Enrollment: | 40 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
patients with age-related macular degeneration, which are already scheduled for intravitreal anti-VEGF therapy in one eye are measured before and after treatment.
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Drug: ranibizumab, bevacizumab or pegaptanib
measurements are performed one week before and after anti-VEGF intravitreal injection
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gerhard Garhöfer, MD | 43-14-0400 ext 2981 | gerhard.garhoefer@meduniwien.ac.at |
Austria | |
Department of Clinical Pharmacology, Medical University of Vienna | Recruiting |
Vienna, Austria, 1090 |
Principal Investigator: | Gerhard Garhöfer, MD | Depatement of Clinical Pharmacology, Medical University of Vienna |
Responsible Party: | Department of Clinical Pharmacology, Medical University of Vienna ( Gerhard Garhöfer, MD ) |
Study ID Numbers: | OPHT-060707 |
Study First Received: | July 1, 2008 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00709657 |
Health Authority: | Austria: Agency for Health and Food Safety |
Age-related macular degeneration anti-VEGF |
Eye Diseases Retinal Degeneration Macular Degeneration |
Bevacizumab Retinal Diseases Retinal degeneration |
Antineoplastic Agents Therapeutic Uses Growth Substances Physiological Effects of Drugs |
Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |