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AS Beckendorf, U Schmidt-Erfurth; A Prospective Randomized Trial Comparing the Standard Regimen in Photodynamic Therapy (PDT) to Earlier / Less Frequent Retreatments . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3980.
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Purpose: To compare the efficacy of a new treatment strategy compared to the standard approved verteporfin therapy in respect to the change in mean visual acuity in patients with predominantly classic subfoveal lesions in age-related macular degeneration (AMD). Methods: A randomized, multi-center clinical trial is carried out in 200 patients. Eligibility is evaluated by a central reading center based on the angiographic presence of predominantly classic subfoveal choroidal neovascularization (CNV) due to AMD and a visual acuity of at least 20/200. PDT using verteporfin is performed, at a drug dose of 6 mg/mm2 body surface area and a light dose of 50 J/cm2. Patients are randomized 1:1 to group A or B: Group A receives treatments at 2 months intervals during the first 6 months and retreatment beyond 6 months at 3 months intervals only if leakage is associated with vision loss of at least one line. Group B is treated according to the TAP criteria with retreatment at 3 months whenever leakage is present angiographically throughout the entire follow-up. Results: Until 12/2001 150 patients were recruited and randomized. All eyes included met the eligibility criteria with active subfoveal CNV and a predominantly classic component. The mean age was 74 years ranging from 65 to 89 years. The mean visual acuity at baseline was 20/100 measured as best-corrected vision on ETDRS charts. The greatest lesion diameter (GLD) at baseline was on average 2.300 µm. The mean follow-up currently is 8.5 months. No ocular or systemic adverse events beyond the rate and risks reported for the TAP investigation were noted. Conclusion: Retreatments in shorter intervals of 2 months are not associated with an increased rate of adverse events. A potential improvement of vision outcome will be evaluated in a 6 month interim analysis.
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