A Randomized, Controlled Study of the Safety and Preventive Efficacy of Oral Ganciclovir When Used in Conjunction With An Intravitreal Ganciclovir Implant in the Treatment of Cytomegalovirus Retinitis

Exclusion Criteria

• •Co-existing Condition:
• •Patients with the following symptoms or conditions are excluded:
• •Chronic, clinically significant diarrhea, nausea, abdominal pain,or other symptoms of uncontrolled gastrointestinal disease.
• •Ocular opacities (corneal, aqueous, lens, or vitreous) preventing ophthalmologic retinal assessment of fundus photography.
• •Acute retinal necrosis or any other intraocular condition that might preclude study completion.
• •Ocular condition requiring immediate surgery.
• •Unable to have long-term IV catheter placement.
• •Concurrent Medication:
• •Excluded:
• •Vidarabine.
• •Amantadine hydrochloride.
• •Cytarabine.
• •FIAC or FIAU.
• •Idoxuridine.
• •Ribavirin.
• •Valacyclovir.
• •Foscarnet.
• •CMV hyperimmune globulin.
• •Soluble CD4.
• •Trichosanthin.
• •Imipenem-cilastatin.
• •Isoprinosine.
• •Levamisole.
• •Interferon.
• •Other investigational drugs.
• •Patients with the following prior conditions are excluded:
• •History of previous invasive intraocular surgery of any kind in the involved eye or any condition for which ocular surgery is contraindicated.
• •History of hypersensitivity to acyclovir or ganciclovir.
• •Prior Medication:
• •Excluded:
• •Any prior oral ganciclovir in a CMV retinitis treatment protocol OR more than 4 months of prior oral ganciclovir in a prophylaxis study (per amendment).
• •Prior intravitreal ganciclovir implant.
• •More than two prior induction dose courses of IV anti-CMV therapy (per amendment).
• •Intravitreal injection of any antiviral medication within the past 4 weeks (per amendment).