A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )
2 other identifiers
interventional
194
1 country
18
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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 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:
- +18 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
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 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 and Throat Association
Charlotte, North Carolina, 28204, 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
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)
Intervention 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