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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Enrollment
60
Retina - Vitreous Associates Med Group
Los Angeles, California, United States
Community Eye Med Group
Pasadena, California, United States
Santa Clara Valley Med Ctr
San Jose, California, United States
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Univ of Colorado Health Sciences Ctr
Denver, Colorado, United States
Dr Julio Perez
Fort Lauderdale, Florida, United States
Georgia Retina
Atlanta, Georgia, United States
Univ of Illinois
Chicago, Illinois, United States
Indiana Univ Med Ctr
Indianapolis, Indiana, United States
Vitreo - Retinal Consultants
New York, New York, United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, United States
...and 3 more locations