Ganciclovir clinical studies

Ganciclovir
VITRASERT® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Clinical Studies
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Clinical Studies

In a randomized, controlled parallel group trial conducted between May 1993 and December 1994, treatment with the Vitrasert Implant was compared to treatment with intravenous ganciclovir (Cytovene-IV; Roche) in 188 patients with AIDS and newly diagnosed CMV retinitis. Patients randomized to the Cytovene-IV treatment group received Cytovene-IV solution at induction doses (5 mg/kg twice daily) for 14 days, followed by maintenance dosing (5 mg/kg once daily). Based on masked assessment of fundus photographs, the median time to progression was approximately 210 days for the Vitrasert Implant treatment group compared to approximately 120 days for the intravenous ganciclovir treatment group.

References

Adapted from the FDA Package Insert.