Treatment Review #16; January 1995
The treatment is called ISIS 2922. ISIS 2922 is an antisense drug. Antisense affects the way the CMV virus works. Antisense may be able to destroy the virus without harming the person. Current treatments that kill viruses and cancer cells may also destroy healthy cells in the body and weaken immune systems.
The first trial will study ISIS 2922 alone for the treatment of CMV retinitis. Participants will be divided into two groups. One group will be treated with the study drug. The other group will not be treated until disease progression is observed. The study drug is given by injection into the globe of the eye once a week for three weeks, and then once every other week.
Each participant will be followed for approximately 20 weeks. Participants can continue treatment after the end of the study. To participate in this study, you must have newly diagnosed peripheral CMV retinitis in one eye. Peripheral means that it doesn't threaten your vision. You cannot have an opportunistic infection outside of the eye, including CMV in other parts of the body.
The second trial will study ISIS 2922 and ganciclovir. This trial will compare the combination of ISIS 2922 and ganciclovir to ganciclovir alone for the treatment of CMV retinitis. Participants must have CMV retinitis that has progressed at least once while being treated with ganciclovir or foscarnet. Participants will be divided into two groups. The first group will be treated with both drugs for three weeks, and then with ISIS 2922 alone. The second group will be treated with ganciclovir. ISIS 2922 will be given by injection into the globe of the eye once per week for three weeks and then once every other week. Ganciclovir is given by intravenous infusion. Participants will be followed for approximately 20 weeks and will be offered the opportunity to continue therapy with ISIS 2922 after this period. To participate, you must have CMV retinitis in one or both eyes that has progressed at least once while being treated with ganciclovir or foscarnet. You cannot be intolerant to ganciclovir. If you are interested in these studies, call The Network at (800) 734-7104.
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