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

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

A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

60

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

  • United States
    • California
      • Los Angeles, California, United States, 90017
        • Retina - Vitreous Associates Med Group
      • Pasadena, California, United States, 911052536
        • Community Eye Med Group
      • San Jose, California, United States, 95128
        • Santa Clara Valley Med Ctr
    • Colorado
      • Denver, Colorado, United States, 80262
        • Univ of Colorado Health Sciences Ctr
    • Florida
      • Fort Lauderdale, Florida, United States, 33060
        • Dr Julio Perez
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Georgia Retina
    • Illinois
      • 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, 10028
        • Vitreo - Retinal Consultants
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Charlotte Eye Ear Nose & Throat Association
    • Texas
      • Dallas, Texas, United States, 752359057
        • Univ of Texas Southwestern Med Ctr of Dallas
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Eye Consultants
    • 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

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.

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

Collaborators and Investigators

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

Sponsor

Ionis Pharmaceuticals, Inc.

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

July 1, 1998

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251A
  • ISIS 2922-CS2

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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