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| Sponsored by: |
Medical University of Vienna |
| Information provided by: | Medical University of Vienna |
| ClinicalTrials.gov Identifier: | NCT00523406 |
Purpose
To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using reduced fluence compared to the standard fluence.
| Condition | Intervention | Phase |
|
Macular Degeneration |
Procedure: Photodynamic therapy and intravitreal triamcinolone |
Phase III |
| Genetics Home Reference related topics: | X-linked juvenile retinoschisis |
| MedlinePlus related topics: | Macular Degeneration |
| ChemIDplus related topics: | Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Enrollment: | 40 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | October 2007 |
| Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
A: Active Comparator
standard fluence photodynamic therapy and intravitreal triamcinolone combination
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Procedure: Photodynamic therapy and intravitreal triamcinolone
combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD
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B: Active Comparator
reduced fluence photodynamic therapy and intravitreal triamcinolone combination
|
Procedure: Photodynamic therapy and intravitreal triamcinolone
combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD
|
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.
Eligibility
| Ages Eligible for Study: | 50 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion Criteria:
Contacts and Locations| Austria | |||||
| Medical University of Vienna, Department of Ophthalmology | |||||
| Vienna, Austria, 1090 | |||||
| Medical University of Vienna |
| Principal Investigator: | Ursula Schmidt-Erfurth, MD, Prof. | Department of Ophthalmology, MUVienna |
More Information
| Responsible Party: | Medical University of Vienna ( PRiv. Doz. Dr. Stefan Sacu ) |
| Study ID Numbers: | EK049/2005 |
| First Received: | August 29, 2007 |
| Last Updated: | May 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00523406 |
| Health Authority: | Austria: Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Unternehmenskommunikation |
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