TreatmentUpdate 72, Vol. 8, No. 8; October 1996
Sean Hosein

Doctors in San Diego recruited 35 volunteers (subjects) with AIDS who also had CMV-retinitis. These subjects "did not benefit from or could not tolerate or refused iv (intravenous) ganciclovir or foscarnet." The study lasted for about 1.5 years and subjects remained in the study until:

* death 31% (of subjects)

* the study ended 17%

* they developed CMV infection in another part of the body 14%

* they developed another serious illness 9%

* they had a detached retina 3%

* they developed complications from the eye injections 9%

* they refused to visit the study doctors as scheduled 3%.

There were 34 males and 1 female in the study. Doctors divided the subjects into groups, A and B. In group A, "twenty-four eyes in 18 subjects" received injections of cidofovir. This was the first time they had received anti-CMV drugs. The twenty-nine eyes of the 17 remaining subjects had been previously treated with "ganciclovir, foscarnet or both."

Eye injections -- the details

Before the subjects received cidofovir they took probenecid 2 g orally and eight hours after the injections, 1 g to reduce the toxicity of cidofovir. They had their eye(s) and eye-lid(s) disinfected with Betadine(R) surgical scrub and then a mild anesthetic was sprayed. The eye(s) was then injected with a stronger anesthetic (Lidocaine 2%). Another injection containing cidofovir 20 micrograms followed. To lower the risk of bacterial infections in the eye, subjects used Polysporin ointment and to the reduce swelling and redness doctors gave them prednisolone eye drops. They received further injections of cidofovir every 6 weeks. On average subjects received 5 injections.

Results

Group A: "None of the eyes in group A had [retinitis which grew worse] during the study." Group B: "Four eyes (from two subjects) had [retinitis which grew worse]" during the study. These eyes belonged to two subjects who had retinitis which did not improve when previously treated with iv "ganciclovir or foscarnet." Eventually the damage to the retina in these two subjects healed.

Complications -- major

No intervention such as putting pellets of slow-release ganciclovir or, injecting eyes with cidofovir is 100% risk-free. Five eyes had reduced vision due to complications:

* two eyes had reduced pressure inside the eyeball and this permanently reduced their vision to "counting fingers."

* one eye could only detect "hand motions...despite rapid healing of the retinitis."

* One eye underwent a reduction of vision due to a temporary drop in pressure inside the eyeball. "This [person also] became ill and [was] unable to return "[to the study clinic]."

Complications -- minor

Parts of the eye became swollen because of the injections but this problem cleared when the subjects used eye-drops containing prednisolone 1% and other drugs designed to reduce swelling.

Survival

Two thirds of subjects in group A died at the end of the study. Half of these subjects lived for 33 weeks. About 60% of subjects in group B died by the end of the study, half of whom lived for 47 weeks but the difference between the groups was not statistically significant.

REFERENCES:

1. Rahhal FM, Arevalo F, Mungia D, et al . Intravitreal cidofovir for the maintenance treatment of cytomegalovirus retinitis. Ophthalmology 1996;103:1078-1083.

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