Treatment Review #16; January 1995

Between October 1992 and December 1993, study sites in Bethesda, Maryland and Atlanta, Georgia enrolled 26 participants with newly diagnosed CMV retinitis. Participants were divided into two groups. One group was given the implant immediately and the second group was given the implant if the retinitis got worse. Participants in the study had no progression of newly diagnosed CMV retinitis for about eight months using the ganciclovir implant. Among those who received no immediate treatment, the eye infection worsened in about 15 days. Although surgery is required to use the implant, the procedure is performed under local anesthesia, takes less than one hour, and can be done on an outpatient basis.

The implants are designed to release ganciclovir over a period of months. The best time for replacement of the implant is unknown. In the study, the implants released the drug at different rates, making it hard to know when the implant needed to be replaced. The current information is that implants should be replaced after 32 weeks to lessen the likelihood of a relapse.

Most participants in the study enjoyed good vision with the implant. By the final followup eye examination, 34 of 39 eyes treated with the implant had nearly perfect vision (20/25). The researchers also reported that nearly all affected eyes had blurred vision immediately after receiving the ganciclovir implant. Normal vision returned on average within 4 weeks.

Because the implant releases ganciclovir into the eye only, there is concern that those who receive the treatment may develop CMV infections in their unaffected eye and elsewhere in the body. In this study, the researchers reported a high rate of infection in the second eye. Of the 21 patients who entered the study with only one eye affected, 14 developed CMV retinitis in the other eye. Doctors treated 11 of these patients with ganciclovir implants in their second eye with similar good results. In addition, eight of the 26 study participants developed CMV infections in other organs. These patients were treated with either intravenous ganciclovir or foscarnet, the approved treatments for CMV.

A study comparing different treatments for CMV retinitis is enrolling. Participants will be divided into three groups. The first group will be treated with standard IV ganciclovir. The second group will be treated with a ganciclovir implant along with oral ganciclovir. The third group will be treated with an implant plus placebo. In the two groups receiving the implant and oral ganciclovir or placebo, neither the participant nor the doctor will know if they are taking oral ganciclovir or placebo. To participate, you must only have CMV retinitis in one eye. Participants who develop CMV disease in other parts of their body must go off the study but may receive an implant and oral ganciclovir. Clinic visits will be every 2 weeks. The implant is also available from the drug company through a compassionate use program if you are unable to take other treatments. Call The Network for more information.

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