NCT00523406

Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

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 mW/cm²) with standard fluence (600 mW/cm²) 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.

Conditions

• Macular Degeneration

Interventions

Type	Name	Description
PROCEDURE	Photodynamic therapy and intravitreal triamcinolone	combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD

Timeline

• Start date: 2005-08-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-08-31
• Last updated: 2013-05-03

Locations

1 site across 1 country: Austria