A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

Completed · Not applicable

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To determine a clinically safe and effective dose of intravitreally injected ISIS 2922 and to compare the safety and efficacy of immediate versus delayed treatment in AIDS patients with previously untreated, peripheral cytomegalovirus ( CMV ) retinitis.

Key facts

Study ID

NCT00002355

Run by

Ionis Pharmaceuticals, Inc.

People needed

60

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have:
• AIDS.
• Clinical diagnosis of previously untreated peripheral CMV retinitis in one eye.
• Leading edge of a CMV retinitis lesion is at least 750 microns from zone one. NOTE:
• Patients with CMV retinitis in zone three only may be eligible if the lesions can be reliably photographed to follow progression.

You may not qualify if…

• Co-existing Condition:
• Patients with the following symptoms or conditions in the eye to be treated are excluded:
• External ocular infections.
• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
• Ocular conditions that will obstruct visualization of the posterior ocular structures.
• Retinal detachment.
• Silicone oil in eye.
• Patients with the following other symptoms or conditions are excluded:
• Known or suspected allergy to phosphorothioate oligonucleotides.
• Syphilis.
• Pseudoretinitis pigmentosa.
• Concurrent Medication:
• Excluded:
• Current treatment for extra-ocular CMV infection.
• Ganciclovir.
• Foscarnet.
• Mellaril.
• Stelazine.
• Thorazine.
• Clofazimine.
• Ethambutol/fluconazole combination.
• Investigational medications for CMV retinitis.
• Concurrent Treatment:
• Excluded:
• Investigational procedures for CMV retinitis.

Where it is running

• Retina - Vitreous Associates Med Group — Los Angeles, California, United States
• Community Eye Med Group — Pasadena, California, United States
• Santa Clara Valley Med Ctr — San Jose, California, United States
• Univ of Colorado Health Sciences Ctr — Denver, Colorado, United States
• Dr Julio Perez — Fort Lauderdale, Florida, United States
• Georgia Retina — Atlanta, Georgia, United States
• Univ of Illinois — Chicago, Illinois, United States
• Indiana Univ Med Ctr — Indianapolis, Indiana, United States
• Vitreo - Retinal Consultants — New York, New York, United States
• Charlotte Eye Ear Nose & Throat Association — Charlotte, North Carolina, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States
• Novum Inc — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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