The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus (CMV) of the Eyes
An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome (AIDS) Patients With Cytomegalovirus Retinitis (NOTE: Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial)
2 other identifiers
interventional
N/A
1 country
25
Brief Summary
To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus ( CMV ) retinitis who are unresponsive or intolerant to ganciclovir and/or foscarnet but are otherwise ineligible for ISIS Pharmaceuticals' controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial. PER 2/8/96 AMENDMENT: Patients must rollover from another ISIS 2922 controlled trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
25 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedJune 24, 2005
December 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Patients must have:
- AIDS.
- CMV retinitis in one or both eyes that was previously treated but is presently uncontrolled.
- Intolerance or resistance to other therapies.
You may not qualify if:
- Co-existing Condition:
- Patients with the following symptoms or conditions are excluded:
- Eligibility to participate in a controlled clinical trial of ISIS 2922.
- External ocular infection in eye to be treated.
- Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other diseases of the fundus in eye to be treated.
- Ocular condition that would obstruct visualization of the posterior ocular structures in eye to be treated.
- Retinal detachment in eye to be treated.
- Known or suspected allergy to phosphorothioate oligonucleotides.
- Silicone oil in eye to be treated.
- Syphilis.
- Clinical evidence of retinal pigment epithelial stippling.
- Pseudoretinitis pigmentosa.
- Concurrent Medication:
- Excluded:
- Foscarnet.
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
UCI College of Medicine
Irvine, California, 92715, United States
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017, United States
Community Eye Med Group
Pasadena, California, 911052536, United States
San Diego Naval Hosp
San Diego, California, 92134, United States
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, 94110, United States
Santa Clara Valley Med Ctr
San Jose, California, 95128, United States
Univ of Colorado Health Sciences Ctr
Denver, Colorado, 80262, United States
Dr Alan Palestine
Washington D.C., District of Columbia, 20036, United States
Dr Julio Perez
Fort Lauderdale, Florida, 33060, United States
Bascon Palmer Eye Institute
Miami, Florida, 33136, United States
Emory Univ School of Medicine / Emory Eye Ctr
Atlanta, Georgia, 30322, United States
Georgia Retina
Atlanta, Georgia, 30327, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202, United States
Tulane Univ
New Orleans, Louisiana, 70112, United States
Vitreo - Retinal Consultants
New York, New York, 10028, United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, 28204, United States
Duke Univ
Durham, North Carolina, 27710, United States
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 19102, United States
Graduate Hosp
Philadelphia, Pennsylvania, 191461192, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359057, United States
Vitreoretinal Consultants
Houston, Texas, 77004, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Virginia Eye Consultants
Norfolk, Virginia, 23507, United States
Novum Inc
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Masking
- NONE
- Purpose
- TREATMENT
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Last Updated
June 24, 2005
Record last verified: 1998-12