Ranibizumab to Treat Choroidal Neovascularization (CNV) in Patients With Pseudoxanthoma Elasticum (PXE)
|ClinicalTrials.gov Identifier: NCT00510965|
Recruitment Status : Completed
First Posted : August 3, 2007
Last Update Posted : June 15, 2012
|Condition or disease||Intervention/treatment||Phase|
|Choroidal Neovascularization||Drug: Intravitreal injection ranibizumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ranibizumab in Choroidal Neovascularization (CNV) Due to Pseudoxanthoma Elasticum (PXE, Groenblad-Strandberg-Syndrome)|
|Study Start Date :||August 2007|
|Actual Primary Completion Date :||April 2010|
|Actual Study Completion Date :||April 2010|
Drug: Intravitreal injection ranibizumab
Monthly intravitreal injection of 0.5mg ranibizumab in one eye over one year
Other Name: Lucentis
- Best corrected visual acuity [ Time Frame: one year ]
- Reading ability [ Time Frame: one year ]
- Changes in retinal thickness assessed by optical coherence tomography [ Time Frame: one year ]
- Changes in parafoveal leakage assessed by fluorescein angiography [ Time Frame: one year ]
- Quality of life [ Time Frame: one year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00510965
|University of Bonn|
|Bonn, Germany, 53127|
|Principal Investigator:||Frank G. Holz, MD||University of Bonn, Department of Ophthalmology|
|Principal Investigator:||Hendrik PN Scholl, MD, MA||University of Bonn|