Choroidal Neovascularization Clinical Trial
Official title:
Ranibizumab in Choroidal Neovascularization (CNV) Due to Pseudoxanthoma Elasticum (PXE, Groenblad-Strandberg-Syndrome)
The purpose of the study is to investigate the efficacy of a new drug called ranibizumab in the treatment of choroidal neovascularization in underlying angioid streaks due to Pseudoxanthoma elasticum. 10 patients will receive monthly injections of the drug in one eye over a period of one year.
Pseudoxanthoma elasticum (PXE) is a rare hereditary systemic disease affecting mainly the
skin, eyes and the cardiovascular system. Commonly, complicating choroidal
neovascularization (CNV) of the central retina lead to a severely decreased visual acuity in
the course of the disease. Onset of the symptoms varies with the extend of the
PXE-associated findings.
In the past there has been no effective treatment for the disease's ocular complications.
Recent studies in a limited number of patients with CNV treated with intravitreal injections
of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF), have
shown a preservation of function and regression of CNV. An increase of visual acuity was
reported in a subset of patients. Bevacizumab is a humanized antibody of which ranibizumab
is a fragment.
This trial is initiated in order to investigate the effect of ranibizumab on functional
outcome measures such as preservation of visual acuity as well as morphological outcome
measures such as regression of CNV in angiography.
The safety and tolerability of ranibizumab will be investigated as well. As it has been
tested on large numbers of patients suffering from age-related macular degeneration with
only rare significant side effects or adverse events being reported, a good safety profile
is assumed.
The study is conducted in a non-randomized, uncontrolled prospective setting at one center.
Patients will receive monthly injections over a period of one year.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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