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

A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis

The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) 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.

  1. 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.