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A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis | Clinical Trials | Clareo Health

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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

NCT00002187•Ionis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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

Detailed Description

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

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.
+11 more criteria

Locations (17)

Retina - Vitreous Associates Med Group

Los Angeles, California, United States

Community Eye Med Group

Pasadena, California, United States

Univ of California San Francisco / SF Gen Hosp

San Francisco, California, United States

Dr Jacob Lalezari

San Francisco, California, United States

Dr Alan Palestine

Washington D.C., District of Columbia, United States

Dr Julio Perez

Fort Lauderdale, Florida, United States

Georgia Retina

Atlanta, Georgia, United States

Chicago Ctr for Clinical Research

Chicago, Illinois, United States

Univ of Illinois

Chicago, Illinois, United States

Indiana Univ Med Ctr

Indianapolis, Indiana, United States

Key Dates

Last Updated

June 24, 2005

Conditions

Cytomegalovirus RetinitisHIV Infections

Interventions

Fomivirsen sodium

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2005Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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