Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Roche Global Development
Patients receive intravitreal ganciclovir implant plus oral ganciclovir, intravitreal implant alone, or IV ganciclovir.
Age
13–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Concurrent Medication:
Allowed:
Topical drugs and ophthalmics.
Patients must have:
AIDS.
Unilateral CMV retinitis.
You may not be if
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).
