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

Launched by IONIS PHARMACEUTICALS, INC. · Aug 30, 2001

Keywords

ClinConnect Summary

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

Gender

ALL

Eligibility 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.