PURPOSE: To report data regarding the safety of intravitreous fomivirsen for treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). DESIGN: Critical review of safety data from three randomized controlled clinical trials with supplemental information from an expanded drug access program. METHODS:Adverse ocular events reported by clinician investigators were listed using terms modified from the COSTART dictionary. Data for two doses (165-microg/injection [35 eyes, 30 patients] and 330-microg/injection [153 eyes, 120 patients]) and two 330-microg/injection dose schedules of different intensity were pooled to calculate incidence rates for each event. Rates were calculated as "events/patient-year" (based on total cumulative reported events and duration of treatment) for events that could recur during treatment. Rates were calculated as "patients with events/person-year" for the following events: retinal detachment, cataract, visual field disturbance, and retinal pigment epitheliopathy. To assess the ability to manage events, we reviewed treatments given for two events (anterior chamber inflammation, increased intraocular pressure) in one trial. We also report an analysis comparing the proportion of eyes that developed one or more key events to the cumulative number of injections. RESULTS:Incidence rates were dose and schedule dependent (165 microg/injection, 4.06 events/patient-year; 330 microg/injection, 6.58 events/patient-year [less intense regimen] and 8.35 events/patient-year [more intense regimen]). The most frequently reported events were anterior chamber inflammation and increased intraocular pressure. We found no evidence that the proportion of patients with events increased as the number of injections increased. CONCLUSIONS:Intravitreous fomivirsen is well tolerated with an acceptable safety profile. Adverse ocular events associated with doses and schedules used clinically can be managed successfully with medical therapy.
RCT Entities:
PURPOSE: To report data regarding the safety of intravitreous fomivirsen for treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). DESIGN: Critical review of safety data from three randomized controlled clinical trials with supplemental information from an expanded drug access program. METHODS: Adverse ocular events reported by clinician investigators were listed using terms modified from the COSTART dictionary. Data for two doses (165-microg/injection [35 eyes, 30 patients] and 330-microg/injection [153 eyes, 120 patients]) and two 330-microg/injection dose schedules of different intensity were pooled to calculate incidence rates for each event. Rates were calculated as "events/patient-year" (based on total cumulative reported events and duration of treatment) for events that could recur during treatment. Rates were calculated as "patients with events/person-year" for the following events: retinal detachment, cataract, visual field disturbance, and retinal pigment epitheliopathy. To assess the ability to manage events, we reviewed treatments given for two events (anterior chamber inflammation, increased intraocular pressure) in one trial. We also report an analysis comparing the proportion of eyes that developed one or more key events to the cumulative number of injections. RESULTS: Incidence rates were dose and schedule dependent (165 microg/injection, 4.06 events/patient-year; 330 microg/injection, 6.58 events/patient-year [less intense regimen] and 8.35 events/patient-year [more intense regimen]). The most frequently reported events were anterior chamber inflammation and increased intraocular pressure. We found no evidence that the proportion of patients with events increased as the number of injections increased. CONCLUSIONS: Intravitreous fomivirsen is well tolerated with an acceptable safety profile. Adverse ocular events associated with doses and schedules used clinically can be managed successfully with medical therapy.
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