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U.M. Schmidt–Erfurth, P. Gabel, T. Hohman, PROTECT Study Group; Preliminary Results From an Open–Label, Multicenter, Phase II Study Assessing the Effects of Same–Day Andministration of Ranibizumab (Lucentis(TM)) and Verteporfin PDT (PROTECT Study) . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2960.
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To evaluate the safety and explore the efficacy of same–day administration of verteporfin PDT and intravitreal injection of ranibizumab 0.5mg.
PROTECT is an open label, multicenter, phase II, 9 month study, in patients with predominantly classic or occult subfoveal CNV secondary to AMD. The primary study endpoint is incidence of severe vision loss (≥30 letters loss in BCVA from baseline within 14 days of treatment and persisting >14 days). Secondary endpoints included effect on BCVA. Safety is assessed at intervals after baseline treatment, and after each combination treatment using BCVA measurements, ophthalmic examinations, and adverse event monitoring. Ranibizumab 0.5mg is administered at baseline (month 0) within 1h of PDT therapy, and then months 1, 2 and 3. Verteporfin PDT is administered at baseline and then at month 3, 6 and 9 as required per standard criteria. A total of 32 patients were recruited 3 cohorts, with each cohort recruited once safety was established in the previous cohorts. The study is ongoing, and data is presented here from the 3 month time period.
At baseline, mean BCVA was 50 letters and the greatest linear diameter of the lesions was 2970 µm. 13 out of the 32 patients presented with predominantly classic lesions. No incidence of severe or moderate vision loss due to choriocapillary nonperfusion or ocular inflammation has been observed up to month 3. The mean change in BCVA from baseline to month 1 was 4.5 letters. The mean visual acuity change from baseline was 3.7 letters for the 12 patients having completed the month 3 assessment. The last patient enrolled in the study will complete 4–month follow–up in December 2005.
Same–day administration of ranibizumab (Lucentis) and verteporfin PDT (Visudyne) did not reveal any new safety concerns. In particular, no inflammatory response was identified in contrast to combination therapy with lyophilized ranibizumab given one week following PDT. Visual acuity findings appear to be as favourable as with continuous ranibizumab monotherapy, although retreatment rates were significantly lower.
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