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S. Wolf, P. Gabel, T.C. Hohman, U. Schmidt–Erfurth, PROTECT study group; Fluorescein Angiographic and OCT Results From an Open–Label, Multicenter, Phase II Study Assessing the Effects of Same–Day Ranibizumab (LucentisTM) and Verteporfin PDT (Visudyne®) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):3542.
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To assess the effect of same–day administration of verteporfin PDT (Visudyne) and intravitreal injection of ranibizumab 0.5mg (Lucentis) on retinal edema and choroidal neovascular (CNV) leakage.
This study is an ongoing, open label, multicenter, phase II, 9 month study, in patients with predominantly classic or occult subfoveal CNV secondary to AMD. A total of 32 patients were recruited. Ranibizumab 0.5mg is administered at baseline (Month 0) and Months 1, 2 and 3. Verteporfin PDT is administered an hour prior to the ranibizumab injection at baseline and then repeated at month 3, 6 and 9 as required per label. The primary study endpoint is incidence and persistence of severe vision loss Secondary endpoints include effect on retinal thickness, recurrence of fluorescein leakage and the need for additional PDT treatments. FA images collected at baseline and at months 3, 4, 6 and 9, as well as OCT assessments performed monthly, are analyzed at a central reading centre.
Fluorescein angiographic results at Month–3 and Month–6 are currently available for 20 and 9 patients, respectively. Fluorescein leakage did not re–occcur in 19 of 20 patients (95%) at Month–3 and in 6 of 9 patients at Month–6. Retinal thickness decreased from 401µm to 225µm and 275µm at baseline to month 3 and 6, respectively. For the 6 patients at month 6 who did not have recurrent leakage from CNV the retinal thickness remained unchanged from month 3 to month 6. The 3 patients who experienced recurrent leakage the retinal thickness increased by approximately 100µm from month 3 to month 6.
Same–day administration of ranibizumab 0.5mg with verteporfin PDT reduces CNV leakage as assessed by fluorescein angiography. This change is accompanied by a significant reduction of retinal thickness.
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