Abstract: |
Objective: To determine the efficacy and safety of intravitreal injection of ganciclovir for active cytomegalovirus (CMV) retinitis in AIDS patients who are intolerant of systemic ganciclovir therapy. Methods: An open-labeled trial of intravitreal ganciclovir induction and maintenance therapy was conducted in outpatient clinics of five AIDS Clinical Trials Units. Sixteen eyes of 11 patients were treated; 11 eyes of eight patients were included in the analysis. Patients were treated with a series of two intravitreal injections per week for the first 3 weeks (induction period), followed by one injection per week until an endpoint was reached or for a total of 24 weeks. Each injection contained 200 μg ganciciovir in a total volume of 0.1 mL, administered through a 30-gauge needle. The primary endpoint measures were the time to retinitis progression as evidenced by the development of a new lesion or progression by more than 750 μm of a preexisting lesion, and progression of CMV as evidenced by development of active disease in the untreated eye or at an extraocular site. Other outcome measures were changes in visual acuity and adverse events related to the intravitreal injections. Results: All of the treated eyes responded to induction therapy, and three eyes were successfully reinduced a total of four times. |