A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

Launched by IONIS PHARMACEUTICALS, INC. · Aug 30, 2001

Keywords

ClinConnect Summary

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....

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Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • AIDS.
• • Clinical diagnosis of previously untreated peripheral CMV retinitis in one eye.
• * Leading edge of a CMV retinitis lesion is at least 750 microns from zone one. NOTE:
• • Patients with CMV retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions in the eye to be treated are excluded:
• • External ocular infections.
• • Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
• • Ocular conditions that will obstruct visualization of the posterior ocular structures.
• • Retinal detachment.
• • Silicone oil in eye.
• Patients with the following other symptoms or conditions are excluded:
• • Known or suspected allergy to phosphorothioate oligonucleotides.
• • Syphilis.
• • Pseudoretinitis pigmentosa.
• Concurrent Medication:
• Excluded:
• • Current treatment for extra-ocular CMV infection.
• • Ganciclovir.
• • Foscarnet.
• • Mellaril.
• • Stelazine.
• • Thorazine.
• • Clofazimine.
• • Ethambutol/fluconazole combination.
• • Investigational medications for CMV retinitis.
• Concurrent Treatment:
• Excluded:
• • Investigational procedures for CMV retinitis.
• Patients with the following prior conditions are excluded:
• • History of surgery to correct retinal detachment in the eye to be treated.
• • History of syphilis.
• Prior Medication:
• Excluded:
• • Prior anti-CMV retinitis treatment in either eye.
• • Anti-CMV therapy for extra-ocular infection within the past 2 days.