Search / Trial NCT00002187

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

Launched by IONIS PHARMACEUTICALS, INC. · Aug 30, 2001

Trial Information

Current as of November 03, 2024

Completed

Keywords

Aids Related Opportunistic Infections Antiviral Agents Drug Administration Schedule Cytomegalovirus Retinitis Fomivirsen Vitreous Body

Description

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

Gender

ALL

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.

About Ionis Pharmaceuticals, Inc.

Ionis Pharmaceuticals, Inc. is a leading biopharmaceutical company specializing in the discovery and development of innovative RNA-targeted therapies for the treatment of various diseases, including neurological disorders, cardiovascular conditions, and rare diseases. With a robust pipeline of drug candidates, Ionis leverages its proprietary antisense technology to modulate gene expression and address unmet medical needs. The company's commitment to advancing precision medicine is underscored by its collaborative partnerships and a strong focus on research and development, positioning Ionis as a pioneer in the field of RNA therapeutics.

Locations

Houston, Texas, United States

Chicago, Illinois, United States

New York, New York, United States

Washington, District Of Columbia, United States

New York, New York, United States

Los Angeles, California, United States

Pasadena, California, United States

San Francisco, California, United States

Fort Lauderdale, Florida, United States

Atlanta, Georgia, United States

Indianapolis, Indiana, United States

Philadelphia, Pennsylvania, United States

Seattle, Washington, United States

Chicago, Illinois, United States

San Francisco, California, United States

Charlotte, North Carolina, United States

Durham, North Carolina, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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