A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis
2 other identifiers
interventional
N/A
1 country
17
Brief Summary
The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
17 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
December 1, 1998
November 2, 1999
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Concurrent Medication:
- 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.
You may not qualify if:
- Co-existing Condition:
- 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.
- \. Systemic anti-CMV therapies other than oral ganciclovir.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017, United States
Community Eye Med Group
Pasadena, California, 911052536, United States
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, 94110, United States
Dr Jacob Lalezari
San Francisco, California, 94115, United States
Dr Alan Palestine
Washington D.C., District of Columbia, 20006, United States
Dr Julio Perez
Fort Lauderdale, Florida, 33060, United States
Georgia Retina
Atlanta, Georgia, 30327, United States
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610, United States
Univ of Illinois
Chicago, Illinois, 60612, United States
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202, United States
New York Univ Med Ctr
New York, New York, 10016, 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, 191021192, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Novum Inc
Seattle, Washington, 98104, United States
Related Publications (2)
New CMV drug won't replace other therapies. AIDS Alert. 1998 Nov;13(11):124-6.
PMID: 11365968BACKGROUNDRoehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6.
PMID: 11365956BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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