A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

Inclusion Criteria

Patients must have:

• AIDS.
• CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
• No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

• External ocular infection.
• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
• Ocular condition 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.
• Retinal pigment epithelial stippling not associated with CMV retinitis.
• Pseudoretinitis pigmentosa.
• Chronic diarrhea that would impair absorption of oral ganciclovir.
• Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

• Foscarnet or other anti-CMV agents other than ganciclovir.
• 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 eye to be treated.
• History of intolerance to ISIS 2922.

Prior Medication:

Excluded:

• Prior ganciclovir implant for CMV retinitis.
• More than 4 months of prior ganciclovir.