Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510965
Status:
COMPLETED
Last Update Posted:
2012-06-15
First Post:
2007-08-01
Brief Title:
Ranibizumab to Treat Choroidal Neovascularization CNV in Patients With Pseudoxanthoma Elasticum PXE
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Ranibizumab in Choroidal Neovascularization CNV Due to Pseudoxanthoma Elasticum PXE Groenblad-Strandberg-Syndrome
Status:
COMPLETED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 diseases 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
In the past there has been no effective treatment for the diseases 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT number 2006-006233-49 | None | None | None |