We performed an open clinical trial to assess the safety and efficacy of a 1 microgram/h ganciclovir implant for the treatment of newly and pretreated cytomegalovirus (CMV) retinitis in patients with the acquired immunodeficiency syndrome (AIDS).
Patients and methods: Thirty-two eyes (20 patients) received the ganciclovir intraocular device and were prospectively followed up from 30 to 365 days. We used a modified technique for fixation of the device in half of the patients. The modification improved the fixation of the implant with a two-hole technique in the strut.
Results: Thirty eyes showed stabilization of the retinitis over the time, but in two patients resistance against ganciclovir and other nucleoside analogue compounds developed. Postoperative complications included vitreous hemorrhage (n = 1), cataract (n = 1), and uveitis anterior (n = 1). Late retinal detachment was seen in five eyes (25%) at 30 to 60 days after implantation. Followup until 1 year after implantation did not show progression of CMV retinitis in 18 to 20 patients. All received antiviral CMV therapy to protect noninfected eyes and intestinum against CMV infection.
Conclusions: The ganciclovir intraocular device seemed to be effective in most cases of CMV retinitis and offers a promising alternative for cytomegalovirus retinitis. Patients pretreated longer than 6 months with i.v. ganciclovir have to be carefully selected for implantation, because resistance against ganciclovir could be three times more likely than in i.v.-therapy naive patients.