A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis
2 other identifiers
interventional
60
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
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
July 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
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.
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017, United States
Community Eye Med Group
Pasadena, California, 911052536, 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 Julio Perez
Fort Lauderdale, Florida, 33060, 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
Vitreo - Retinal Consultants
New York, New York, 10028, United States
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, 28204, United States
Univ of Texas Southwestern Med Ctr of Dallas
Dallas, Texas, 752359057, 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
- not applicable
- 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: 1998-07