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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Fomivirsen

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.