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A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

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, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, fomivirsen, Vitreous Body

Eligibility Criteria

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

Inclusion Criteria 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. Exclusion Criteria 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. 1. Systemic anti-CMV therapies other than oral ganciclovir. Mellaril, Stelazine, chlorpromazine and clofazimine. Combination use of ethambutol and fluconazole. Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated. Ganciclovir implant delivery device in the eye to be treated. Ganciclovir other than oral. Foscarnet.

Sites / Locations

  • Retina - Vitreous Associates Med Group
  • Community Eye Med Group
  • Univ of California San Francisco / SF Gen Hosp
  • Dr Jacob Lalezari
  • Dr Alan Palestine
  • Dr Julio Perez
  • Georgia Retina
  • Chicago Ctr for Clinical Research
  • Univ of Illinois
  • Indiana Univ Med Ctr
  • New York Univ Med Ctr
  • Vitreo - Retinal Consultants
  • Charlotte Eye Ear Nose & Throat Association
  • Duke Univ
  • Hahnemann Univ Hosp
  • Baylor College of Medicine
  • 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
NCT00002187
Brief Title
A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Official Title
A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 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
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
Detailed Description
This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

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, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, fomivirsen, Vitreous Body

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment

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 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. Exclusion Criteria 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. 1. Systemic anti-CMV therapies other than oral ganciclovir. Mellaril, Stelazine, chlorpromazine and clofazimine. Combination use of ethambutol and fluconazole. Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated. Ganciclovir implant delivery device in the eye to be treated. Ganciclovir other than oral. Foscarnet.
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
Univ of California San Francisco / SF Gen Hosp
City
San Francisco
State/Province
California
ZIP/Postal Code
94110
Country
United States
Facility Name
Dr Jacob Lalezari
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Dr Alan Palestine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20006
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
Chicago Ctr for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
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
New York Univ Med Ctr
City
New York
State/Province
New York
ZIP/Postal Code
10016
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
Duke Univ
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Hahnemann Univ Hosp
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
191021192
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Novum Inc
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
11365968
Citation
New CMV drug won't replace other therapies. AIDS Alert. 1998 Nov;13(11):124-6.
Results Reference
background
PubMed Identifier
11365956
Citation
Roehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6.
Results Reference
background

Learn more about this trial

A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis

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