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

June 23, 2005 updated by: Ionis Pharmaceuticals, Inc.

A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis

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

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90017
        • Retina - Vitreous Associates Med Group
      • Pasadena, California, United States, 911052536
        • Community Eye Med Group
      • San Francisco, California, United States, 94110
        • Univ of California San Francisco / SF Gen Hosp
      • San Francisco, California, United States, 94115
        • Dr Jacob Lalezari
    • District of Columbia
      • Washington, District of Columbia, United States, 20006
        • Dr Alan Palestine
    • Florida
      • Fort Lauderdale, Florida, United States, 33060
        • Dr Julio Perez
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Georgia Retina
    • Illinois
      • Chicago, Illinois, United States, 60610
        • Chicago Ctr for Clinical Research
      • Chicago, Illinois, United States, 60612
        • Univ of Illinois
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana Univ Med Ctr
    • New York
      • New York, New York, United States, 10016
        • New York Univ Med Ctr
      • New York, New York, United States, 10028
        • Vitreo - Retinal Consultants
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Charlotte Eye Ear Nose & Throat Association
      • Durham, North Carolina, United States, 27710
        • Duke Univ
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 191021192
        • Hahnemann Univ Hosp
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Washington
      • Seattle, Washington, United States, 98104
        • Novum Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 2, 1999

First Submitted That Met QC Criteria

August 30, 2001

First Posted (Estimate)

August 31, 2001

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 1998

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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