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S. Wolf, PROTECT Study Group; Nine Month Exploratory Endpoint Results From an Open-Label, Multicenter, Phase II Study of Same-Day Verteporfin and Ranibizumab 0.5mg (PROTECT Study), as Measured Using Optical Coherence Tomography (OCT), Fundus Photography and Fluorescein Angiography (FA). Invest. Ophthalmol. Vis. Sci. 2007;48(13):2871.
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To evaluate the effects of same-day administration of verteporfin and intravitreal injection of liquid ranibizumab 0.5mg on lesion parameters as measured by OCT, fundus photography and FA.
PROTECT is an open label, multicenter, Phase II, 9 month study, in patients with predominantly classic (n=13) or occult (n=19), subfoveal CNV secondary to AMD. Patients were randomized into 3 cohorts (n=12, n=10, n=10). Cohort treatment was initiated sequentially at intervals of >30 days based on tolerance in the preceding cohort. Verteporfin PDT was administered at baseline and then at months 3, 6 & 9 if leakage was present on FA. Ranibizumab 0.5mg was administered at baseline within 1 hour after verteporfin therapy, and then monthly for 3 months (4 injections). Exploratory endpoints included mean change from baseline in retinal thickness at months 1,2,3,4,6 and 9 as measured by OCT, and lesion characteristics as measured by fundus photography and FA at months 3,4,6 and 9.
At baseline, 26/28 patients (93%) with OCT measurements had intraretinal edema. During the study, retinal thickness decreased by an average of 173µm at Month 1, from a baseline of 404µm to 230µm. The decrease was maintained throughout the study with verteporfin PDT maintenance therapy as required, with a mean retinal thickness of 232µm at month 9. Fundus photography and FA were performed, with measurements at baseline and at months 3,4,6 and 9. Mean lesion area (8.0mm2 to 7.3mm2), mean greatest linear dimension (GLD) of CNV (3367µm to 3230µm) and FA leakage (8.2mm2 to 7.5mm2) were all reduced from baseline at month 9. During the nine months 69% of patients required one initial verteporfin PDT, and only 9% required the maximum 3 possible verteporfin treatments.
Same-day treatment with ranibizumab 0.5mg and verteporfin PDT produced significant reductions in retinal thickness at one month which were maintained over 9 months. Lesion area, GLD and leakage also declined slightly from baseline over 9 months.
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