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Document 0476
DOCN M9480476
TI Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial. 4. Visual
outcomes. Studies of Ocular Complications of AIDS Research Group in
collaboration with the AIDS Clinical Trials Group.
DT 9410
SO Ophthalmology. 1994 Jul;101(7):1250-61. Unique Identifier : AIDSLINE
MED/94309875
AB BACKGROUND: Cytomegalovirus (CMV) retinitis is the most common
intraocular infection in patients with the acquired immune deficiency
syndrome (AIDS) and, untreated, is a blinding disorder. The
Foscarnet-Ganciclovir Cytomegalovirus Retinitis Trial is a multicenter,
randomized, controlled, unmasked, clinical trial that compared
ganciclovir and foscarnet as treatments for CMV retinitis in patients
with AIDS. METHODS: Patients with previously untreated CMV retinitis who
enrolled in this trial were assigned randomly to treatment with either
foscarnet or ganciclovir and followed at regular intervals for visual
outcomes, including progression of the retinitis, visual acuity, and
visual fields. In October 1991, the treatment protocol was suspended due
to a greater mortality in the ganciclovir-assigned group. RESULTS: The
efficacy of the two drugs in controlling the CMV retinitis as measured
by the time to first progression was similar. The relative risk for
progression of the retinitis was 0.97 (ganciclovir versus foscarnet; P =
0.833), and the median time to first progression was 53 days in the
foscarnet-assigned patients compared with 47 days in the
ganciclovir-assigned patients (P = 0.997), as determined by a masked
reading at a central fundus photograph reading center. By 120 days after
randomization, progression was observed in 85% of patients in each
treatment group. Visual acuity outcomes were similar for both groups; at
6 months after randomization, 88% of the foscarnet-assigned patients and
93% of the ganciclovir-assigned patients had a best-corrected visual
acuity of 20/40 or better in the better eye (P = 0.325). Visual field
scores were similar in the two groups; in all eyes affected with CMV
retinitis, there was a mean 29 degrees/month loss of visual field in
foscarnet-assigned patients compared with a 31 degrees/month loss in
ganciclovir-assigned patients (P = 0.674). CONCLUSION: Although
foscarnet was associated with a longer survival than ganciclovir, the
two drugs appear equivalent in controlling CMV retinitis and preserving
vision.
DE Adult AIDS-Related Opportunistic Infections/*DRUG THERAPY/MORTALITY
Comparative Study Cytomegalovirus Retinitis/*DRUG THERAPY/MORTALITY
Female Foscarnet/*THERAPEUTIC USE Fundus Oculi
Ganciclovir/*THERAPEUTIC USE Human Lymphocyte Subsets/IMMUNOLOGY Male
Middle Age Photography Support, Non-U.S. Gov't Support, U.S. Gov't,
P.H.S. Treatment Outcome *Visual Acuity Visual Fields CLINICAL TRIAL
JOURNAL ARTICLE MULTICENTER STUDY RANDOMIZED CONTROLLED TRIAL
SOURCE: National Library of Medicine. NOTICE: This material may be
protected by Copyright Law (Title 17, U.S.Code).