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To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.
Full description
In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.
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Inclusion and exclusion criteria
Inclusion Criteria
Patients must have:
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions in the eye to be treated are excluded:
Patients with the following other symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Concurrent Treatment:
Excluded:
Patients with the following prior conditions are excluded:
Prior Medication:
Excluded:
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Data sourced from clinicaltrials.gov
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