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C.D. Regillo, SnET2 Study Group; SnET2 Photodynamic Therapy for Age–Related Macular Degeneration: Safety Results From Two Parallel Phase III Trials . Invest. Ophthalmol. Vis. Sci. 2004;45(13):3190.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose: To present adverse event and other safety data from two Phase III randomized trials evaluating SnET2–PDT over a 2–year period for the treatment of subfoveal CNV secondary to AMD. Methods: Two identical phase III trials evaluated a total of 920 patients. SnET2 doses of 0.5 mg/kg (N=372), 0.75 mg/kg (N=365) or placebo (N=183) were administered to patients approximately 12 minutes prior to 36 J/cm2 light activation, with re–treatment possible every 13 weeks. Adverse events were coded using the WHO–Adverse Reaction Terminology Dictionary and their severity and relationship to treatment were determined by the investigators. Results: The most common adverse events were vision disorders, with incidence similar between the treatment groups and placebo. The most common non–visual event was transient, mild skin photosensitivity, with incidence rates of 1.1, 4.9 and 11.2 events per 100 administrations of placebo, 0.5 and 0.75 mg/kg respectively. The incidence of application site AEs was 1.6, 5.1 and 8.3 percent of total administrations for placebo, 0.5, and 0.75 mg/kg doses respectively. Cumulative exposure to SnET2 (as a consequence of retreatment) was not associated with increased incidence of dermal photosensitivity or application site reactions. Extremely low incidences of infusion–related back pain (placebo=0.22%, 0.5 mg/kg=0.23%, 0.75 mg/kg=0.11%) and acute post–treatment vision loss (placebo=0.22%, 0.5 mg/kg =0.11%, 0.75 mg/kg=0.45%) were reported. Incidence of treatment–related SAEs was also extremely low, occurring in only 4 of 920 patients. These consisted of 1 extravasation following a dose of 0.5 mg/kg and 2 extravasations and 1 allergic reaction following doses of 0.75 mg/kg. Conclusions: The proposed clinical dose of 0.5 mg SnET2/kg was well–tolerated with an excellent safety profile in this patient group.
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