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A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

Primary Purpose

Cytomegalovirus Retinitis, HIV Infections

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fomivirsen sodium
Sponsored by
Ionis Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria 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. Exclusion Criteria 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. Foscarnet. Mellaril. Stelazine. Thorazine. Clofazimine. Ethambutol/fluconazole combination. Investigational medications for CMV retinitis. Concurrent Treatment: Excluded: Investigational procedures for CMV retinitis. Patients with the following prior conditions are excluded: History of surgery to correct retinal detachment in the eye to be treated. History of syphilis. Prior Medication: Excluded: Prior anti-CMV retinitis treatment in either eye. Anti-CMV therapy for extra-ocular infection within the past 2 days.

Sites / Locations

  • Retina - Vitreous Associates Med Group
  • Community Eye Med Group
  • Santa Clara Valley Med Ctr
  • Univ of Colorado Health Sciences Ctr
  • Dr Julio Perez
  • Georgia Retina
  • Univ of Illinois
  • Indiana Univ Med Ctr
  • Vitreo - Retinal Consultants
  • Charlotte Eye Ear Nose & Throat Association
  • Univ of Texas Southwestern Med Ctr of Dallas
  • Virginia Eye Consultants
  • Novum Inc

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
June 23, 2005
Sponsor
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00002355
Brief Title
A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
Official Title
A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 1998
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ionis Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.
Detailed Description
In Stage 1 (dose escalation), patients receive either 75 or 150 mcg intravitreal ISIS 2922. In Stage 2 (randomization), patients are enrolled in either the immediate treatment group or delayed treatment group. Immediate treatment consists of intravitreal ISIS 2922 every 7 days for 3 injections (Induction) then every 14 days for 18 weeks (Maintenance). Patients in the delayed treatment group receive no immediate anti-CMV treatment but are monitored weekly for disease progression. If disease progresses, patient receives ISIS 2922 on an identical dosage regimen as those on immediate treatment. Patients may continue ISIS 2922 on a biweekly extended maintenance schedule if dose is considered safe and the CMV retinitis is clinically controlled. Per 2/8/96 amendment, patients are now in Stage 2 at 150 mcg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cytomegalovirus Retinitis, HIV Infections
Keywords
AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fomivirsen sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Exclusion Criteria 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. Foscarnet. Mellaril. Stelazine. Thorazine. Clofazimine. Ethambutol/fluconazole combination. Investigational medications for CMV retinitis. Concurrent Treatment: Excluded: Investigational procedures for CMV retinitis. Patients with the following prior conditions are excluded: History of surgery to correct retinal detachment in the eye to be treated. History of syphilis. Prior Medication: Excluded: Prior anti-CMV retinitis treatment in either eye. Anti-CMV therapy for extra-ocular infection within the past 2 days.
Facility Information:
Facility Name
Retina - Vitreous Associates Med Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
Community Eye Med Group
City
Pasadena
State/Province
California
ZIP/Postal Code
911052536
Country
United States
Facility Name
Santa Clara Valley Med Ctr
City
San Jose
State/Province
California
ZIP/Postal Code
95128
Country
United States
Facility Name
Univ of Colorado Health Sciences Ctr
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Dr Julio Perez
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33060
Country
United States
Facility Name
Georgia Retina
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30327
Country
United States
Facility Name
Univ of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana Univ Med Ctr
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Vitreo - Retinal Consultants
City
New York
State/Province
New York
ZIP/Postal Code
10028
Country
United States
Facility Name
Charlotte Eye Ear Nose & Throat Association
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Univ of Texas Southwestern Med Ctr of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
752359057
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Novum Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes

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