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[Photodynamic therapy]

Author(s): Soubrane G, Kuhn D, Oubraham H, Coscas G

Affiliation(s): Clinique Ophtalmologique Universitaire de Creteil, Universite Paris-XII, 40 avenue de Verdun, 94010 Creteil.

Publication date & source: 2002-09, J Fr Ophtalmol., 25(7):753-5.

Publication type: Clinical Trial; Randomized Controlled Trial

Photodynamic therapy with Verteporfine (Visudyne Novartis Ophthalmics) achieves a photo occlusion of subfoveal choroidal neovascularization (CNV) resulting from age-related macular degeneration (AMD) in phase 1 and 2 studies. Thereafter, two international randomized clinical trials evaluated the product's efficacy in term of visual acuity. Eyes with neovascular lesions due to AMD of less than 5,400 micro, in size involving the fovea and presenting well-defined CNV on fluorescein angiography could be included when visual acuity was between 5 and 1/10. Six hundred and nine patients were subsequently randomized either to Verteporfine or to placebo (proportion 2:1). A follow-up of 3 months made it possible to consider retreatment when a fluorescein leakage was observed. Functional and angiographic results demonstrated the efficacy of PDT with Verteporfine in comparison with placebo at each examination during follow-up. A visual acuity decrease of less than 15 letters on ETDRS (or 3 lines or approximately 1.5/10) occured less frequently in the treated group with PDT (61% out of 402 treated eyes compared with 46% of 207 placebo eyes). Subgroup analysis of predominantly well-defined CNV (involving 50% or more of the total of the exsudative lesion) showed even more favourable effects (67% of treated eyes versus 39% of placebo eyes). Conversely, when well-defined CNV extended to a smaller area, the results were not significant. The most frequent side effect was Verteporfine extravasation at the injection site. As dynamic phototherapy with Verteporfine limits the decrease in visual acuity always occurring in the natural history of CNV caused by AMD, it is desirable that patients presenting subfoveal predominantly well-defined lesions benefit from this new treatment approach.

Page last updated: 2006-01-31

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