A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
NCT ID: NCT00002187
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
Brief Summary
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Detailed Description
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Conditions
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Study Design
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PARALLEL
TREATMENT
Interventions
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Fomivirsen sodium
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Ionis Pharmaceuticals, Inc.
INDUSTRY
Locations
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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
New York Univ Med Ctr
New York, New York, United States
Vitreo - Retinal Consultants
New York, New York, United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, United States
Duke Univ
Durham, North Carolina, United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Novum Inc
Seattle, Washington, United States
Countries
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References
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Other Identifiers
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ISIS 2922-CS9
Identifier Type: -
Identifier Source: secondary_id
251D
Identifier Type: -
Identifier Source: org_study_id