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

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

Summary

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

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

Details

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

Criteria

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.