A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

Inclusion criteria

Concurrent Medication:

Allowed:

• Oral ganciclovir.
• Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.

Patients must have:

• Documented AIDS.
• Clinical diagnosis of advanced CMV retinitis in 1 or both eyes.
• >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.
• > 25% retinal involvement with CMV retinitis.
• Baseline CMV retinitis lesions which have leading edges > 1000 micrograms from the macula or optic disk.

Prior Medication:

Required:

• >= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.

Allowed:

• All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.

Exclusion criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

• External ocular infection in the eye to be treated.
• Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated.
• Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated.
• Retinal detachment in the eye to be treated.
• Ganciclovir implant in the eye to be treated.
• Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922.
• Silicone oil in the eye to be treated.
• Pseudoretinitis pigmentosa.
• Syphilis.

Patients with the following prior conditions are excluded:

• History of surgery to correct retinal detachment in the eye to be treated.
• History of syphilis.

• Systemic anti-CMV therapies other than oral ganciclovir.
• Mellaril, Stelazine, chlorpromazine and clofazimine.
• Combination use of ethambutol and fluconazole.
• Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated.
• Ganciclovir implant delivery device in the eye to be treated.
• Ganciclovir other than oral.
• Foscarnet.