Abstract :
PURPOE: To ae the efficacy of intravitreou fomiviren odium, an antiene oligonucleotide, for newly diagnoed peripheral cytomegaloviru (CMV) retiniti in patient with acquired immunodeficiency yndrome (AID).
DEIGN: Randomized treatment intervention clinical trial.
METHOD: A multicenter, propective, and randomized clinical trial compared immediate treatment of CMV retiniti with fomiviren (165 μg adminitered intravitreouly) to deferral of treatment until CMV retiniti leion progreed by tandard definition. Included were patient with CMV retiniti leion at leat 750 μm outide of zone 1. Fomiviren wa injected weekly for three doe a induction therapy, followed by injection every other week a maintenance therapy. All patient were examined regularly until evidence of retiniti progreion. Time to firt progreion wa determined by two independent maked fundu photography reading center (principal outcome) and by clinician invetigator baed on indirect ophthalmocopy. Patient in the deferral of treatment group were offered fomiviren therapy at the time of clinically determined retiniti progreion.
REULT: Patient in the immediate treatment group (n = 18) and the deferral of treatment group (n = 10) were comparable at baeline. Median time to firt progreion of dieae for the immediate treatment group wa 71 day (95% confidence interval [CI] 28 day—not determinable) and for the deferral of treatment group wa 13 day (95% CI 9–15 day; P = .0001, Wilcoxon rank um tet). Progreion occurred in 44% of patient in the immediate treatment group during the tudy compared with 70% of patient in the deferral of treatment group during the tudy. There were no retinal detachment among eye treated with fomiviren.
CONCLUION: Fomiviren i an effective treatment for CMV retiniti in patient with AID that utilize a mechanim of action different than that of ganciclovir, focarnet, and cidofovir.
