INITIAL EXPERIENCE WITH AN 8-MONTH SUSTAINED-RELEASE INTRAVITREAL GANCICLOVIR IMPLANT FOR THE TREATMENT OF CMV RETINITIS ASSOCIATED WITH AIDS

BACKGROUND AND OBJECTIVE: An intravitreal device administering gancicl ovir in a sustained-release fashion has been developed for site-specif ic therapy of cytomegalovirus (CMV) retinitis. The initially tested de vices released ganciclovir at a rate of approximately 2 mu g/hour (Mar k I device), yielding an estimated in vivo therapeutic life span of 4 months. This report describes the initial clinical results of a longer -lasting device that releases ganciclovir at a rate of 1 mu g/hour (Ma rk II device), designed to be effective for up to 8 months. PATIENTS A ND METHODS: Over a 15-month time period, a total of 39 Mark II intravi treal ganciclovir devices were placed in 35 eyes of 29 patients with a diagnosis of CMV retinitis. Ar the time of implantation, none of the patients were on systemic anti-CMV therapy. RESULTS: Of the first 29 e yes of the 29 enrolled patients implanted with their initial Mark II d evice, 28 (97%) had no progression of retinitis at the 4-week postoper ative examination. Survival analysis of these initial 29 implants reve aled the median time to disease progression was 29.3 weeks (205 days). Serious ocular complications included one case of acute bacterial end ophthalmitis (2.9% of eyes or 2.5% of implantations), and four cases o f rhegmatogenous retinal detachment (four of 35 or 11.4% of eyes). Of the 10 patients with initially unilateral retinitis, four (40%) eventu ally developed contralateral disease. Five clinically suspected cases of extraocular, systemic CMV disease occurred during the study (17.2 % of patients), necessitating reinstitution of systemic therapy. CONCLU SION: This small, uncontrolled pilot study indicates that the Mark II (1 mg/hour) sustained-release intravitreal ganciclovir device is effec tive for local control of CMV retinitis.