TREATMENT OF CYTOMEGALOVIRUS RETINITIS WITH AN INTRAOCULAR SUSTAINED-RELEASE GANCICLOVIR IMPLANT - A RANDOMIZED CONTROLLED CLINICAL-TRIAL

Background and Methods: We performed a randomized controlled clinical trial to assess the safety and efficacy of a 1 mu g/h ganciclovir impl ant for the treatment of newly diagnosed cytomegalovirus (CMV) retinit is in patients with the acquired immunodeficiency syndrome (AIDS). Pat ients with previously untreated peripheral CMV retinitis were randomly assigned either to immediate treatment with the ganciclovir implant o r to deferred treatment. Standardized fundus photographs were taken at 2-week intervals and analyzed in a masked fashion. The study end poin t was progression of retinitis based on the photographic assessment. R esults: Twenty-six patients (30 eyes) were enrolled. The median time t o progression of retinitis was 15 days in the deferred treatment group (n=16) vs 226 days in the immediate treatment group (n=14) (P<.00001, log-rank test). During the study, 39 primary implants and 12 exchange implants were placed in immediate-treatment eyes, deferred-treatment eyes that progressed, or contralateral eyes that developed CMV retinit is. Postoperative complications in the total series included seven lat e retinal detachments and one retinal tear without detachment. Final v isual acuity was 20/25 or better in 34 of 39 eyes. The estimated risk of developing CMV retinitis in the fellow eye was 50% at 6 months. Bio psy-proven visceral CMV disease developed in eight (31%) of 26 patient s. The median survival was 295 days. Conclusion: The ganciclovir impla nt is effective for the treatment of CMV retinitis. Patients with unil ateral CMV retinitis treated with the implant are likely to develop CM V retinitis in the fellow eye, and some patients will develop visceral CMV disease.