Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00523406
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2007-08-29
Brief Title:
Comparison of Reduced Fluence Versus Standard Photodynamic Therapy in Combination With Intravitreal Triamcinolone Acetate
Sponsor:
Medical University of Vienna
Organization:
Medical University of Vienna
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2013-05
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:
To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using reduced fluence compared to the standard fluence
Detailed Description:
Age-related macular degeneration AMD is by far the most common disorder in the group of irreversible causes of visual disability AMD leads to dysfunction and loss of photoreceptors in the central retina Neovascular AMD affects visual function early in the disease process and severely compromises the highly developed functions of the macula such as perception of details central fixation color vision and reading ability AMD-related visual impairment is associated with a loss of autonomy and quality of life Currently laser photocoagulation photodynamic therapy PDT with verteporfin usually combined with intravitreal triamcinolone acetonide IVTA are the only proved treatments for subfoveal choroidal neovascularisation CNV Laser photocoagulation is limited to selected cases Photodynamic therapy using verteporfin provides very promising data regarding improvement of visual acuity and absence of fluorescein leakage PDT was recently successfully combined with an intravitreal injection of the corticosteroid triamcinolone acetonide Yet PDT also leads to damage to surrounding normal choroidal vessels A pilot trial comparing low fluence 300 mWcm² with standard fluence 600 mWcm² demonstrated a trend for improved outcomes using the low fluence regimen VIM study However vascular mechanisms and choroidal damage were not examined and the study group was too small to evaluate vision outcome parameters Combined with the IVTA the low fluence effects of PDT may be sufficient for CNV occlusion and the physiological choroids should be spared from any collateral damage The aim of this study was to compare reduced fluence with standard fluence PDT using verteporfin and IVTA for CNV secondary to AMD
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