Abstract :
PURPOE: To report data regarding the afety of intravitreou fomiviren for treatment of cytomegaloviru (CMV) retiniti in patient with acquired immunodeficiency yndrome (AID).
DEIGN: Critical review of afety data from three randomized controlled clinical trial with upplemental information from an expanded drug acce program.
METHOD: Advere ocular event reported by clinician invetigator were lited uing term modified from the COTART dictionary. Data for two doe (165-μg/injection [35 eye, 30 patient] and 330-μg/injection [153 eye, 120 patient]) and two 330-μg/injection doe chedule of different intenity were pooled to calculate incidence rate for each event. Rate were calculated a “event/patient-year” (baed on total cumulative reported event and duration of treatment) for event that could recur during treatment. Rate were calculated a “patient with event/peron-year” for the following event: retinal detachment, cataract, viual field diturbance, and retinal pigment epitheliopathy. To ae the ability to manage event, we reviewed treatment given for two event (anterior chamber inflammation, increaed intraocular preure) in one trial. We alo report an analyi comparing the proportion of eye that developed one or more key event to the cumulative number of injection.
REULT: Incidence rate were doe and chedule dependent (165 μg/injection, 4.06 event/patient-year; 330 μg/injection, 6.58 event/patient-year [le intene regimen] and 8.35 event/patient-year [more intene regimen]). The mot frequently reported event were anterior chamber inflammation and increaed intraocular preure. We found no evidence that the proportion of patient with event increaed a the number of injection increaed.
CONCLUION: Intravitreou fomiviren i well tolerated with an acceptable afety profile. Advere ocular event aociated with doe and chedule ued clinically can be managed uccefully with medical therapy.
