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document
Safety of intravitreous fomivirsen for treatment of cytomegalovirus retinitis in patients with AIDS . 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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Intervention_Pharmacological
fomivirsen
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Intervention_Pharmacological
fomivirsen
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Outcome_Adverse-effects
anterior chamber inflammation
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Outcome_Adverse-effects
increased intraocular pressure
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Outcome_Other
proportion of patients with events
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Outcome_Other
number of injections increased .
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Outcome_Other
well tolerated with an acceptable safety profile .
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Outcome_Adverse-effects
Adverse ocular events
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Participant_Condition
cytomegalovirus retinitis in patients with AIDS .
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Participant_Sample-size
30
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Participant_Sample-size
120