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F. G. Holz, PROTECT Study Group; Nine Month Safety and Efficacy Results From an Open-Label, Multicenter, Phase II Study of Same-Day Verteporfin and Ranibizumab 0.5mg (PROTECT Study). Invest. Ophthalmol. Vis. Sci. 2007;48(13):4566.
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To evaluate the safety and explore the efficacy of same-day administration of verteporfin and intravitreal injection of ranibizumab 0.5mg.
PROTECT is an open label, multicenter, Phase II, 9 month study, in patients with predominantly classic (n=13) or occult (n=19) lesions. Patients were randomized into 3 cohorts (n=12, n=10, n=10) with cohort treatment initiated at intervals of >30 days based on preceding cohort tolerance. Verteporfin PDT was administered at baseline and at months 3, 6 and 9 if leakage was present on FA. Ranibizumab 0.5mg was administered within 1 hour of verteporfin at baseline, and then monthly for 3 months (4 injections). The primary endpoint was incidence rate of severe vision loss up to month 4 (≥30 letters loss in BCVA within 14 days and persisting >14 days). The secondary endpoint was the incidence rate of moderate vision loss (≥15 letters loss within 14 days and persisting >14 days). Exploratory endpoints included BCVA and need for verteporfin re-treatment.
Severe vision loss due to ocular inflammation was not observed. Only 1 patient (3.1%) experienced moderate vision loss (within 14 days of combination treatment lasting >14 days). There was 1 case of mild uveitis (3.1%) and 2 cases of moderate uveitis (6.3%). Mean VA improvement at 9mo was 2.4 letters. Ocular AEs included reduced VA (n=6; 18.8%), ocular hyperaemia (n=5; 15.6%), eye pain (n=4; 12.5%), and increased IOP (n=4; 12.5%). Non-ocular AEs included back pain and hypertension (n=3; 9.4% each). 69% of patients (n=22/32) required only initial PDT, 22% (n=7) required 1 additional PDT and only 9% (n=3) required the maximum 3 possible PDT treatments.
Same-day administration of verteporfin PDT and ranibizumab 0.5mg is not associated with severe vision loss. Mean VA remained over baseline with combination therapy. Combination therapy with same-day administration of ranibizumab may reduce the number of subsequent verteporfin PDT treatments required.
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