A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

Completed · Phase 2

Conditions studied: Cytomegalovirus Retinitis, HIV Infections

In brief

To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

Key facts

Study ID

NCT00002156

Run by

Ionis Pharmaceuticals, Inc.

People needed

194

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.
• CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).
• No more than one previous progression of CMV retinitis.

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 infection.
• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.
• Ocular condition 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.
• Retinal pigment epithelial stippling not associated with CMV retinitis.
• Pseudoretinitis pigmentosa.
• Chronic diarrhea that would impair absorption of oral ganciclovir.
• Intolerance to ganciclovir.
• Concurrent Medication:
• Excluded:
• Foscarnet or other anti-CMV agents other than ganciclovir.
• Mellaril.
• Stelazine.
• Thorazine.
• Clofazimine.
• Ethambutol/fluconazole combination.
• Investigational medications for CMV retinitis.
• Concurrent Treatment:
• Excluded:

Where it is running

• Retina - Vitreous Associates Med Group — Los Angeles, California, United States
• Community Eye Med Group — Pasadena, California, United States
• San Diego Naval Hosp — San Diego, California, United States
• Univ of California San Francisco / SF Gen Hosp — San Francisco, 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 and Throat Association — Charlotte, North Carolina, United States
• Hahnemann Univ Hosp — Philadelphia, Pennsylvania, United States
• Graduate Hosp — Philadelphia, Pennsylvania, United States
• Univ of Texas Southwestern Med Ctr of Dallas — Dallas, Texas, United States
• Baylor College of Medicine — Houston, 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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