A randomized controlled clinical trial of intravitreous fomivirsen for treatment of newly diagnosed peripheral cytomegalovirus retinitis in patients with AIDS

American Journal of Ophthalmology
Vitravene Study Group

Abstract

To assess the efficacy of intravitreous fomivirsen sodium, an antisense oligonucleotide, for newly diagnosed peripheral cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Randomized treatment intervention clinical trial. A multicenter, prospective, and randomized clinical trial compared immediate treatment of CMV retinitis with fomivirsen (165 microg administered intravitreously) to deferral of treatment until CMV retinitis lesions progressed by standard definitions. Included were patients with CMV retinitis lesions at least 750 microm outside of zone 1. Fomivirsen was injected weekly for three doses as induction therapy, followed by injection every other week as maintenance therapy. All patients were examined regularly until evidence of retinitis progression. Time to first progression was determined by two independent masked fundus photography reading centers (principal outcome) and by clinician investigators based on indirect ophthalmoscopy. Patients in the deferral of treatment group were offered fomivirsen therapy at the time of clinically determined retinitis progression. Patients in the immediate treatment group (n = 18) and the deferral of treatment group (n = 10) were comparable ...Continue Reading

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