A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Completed · Not applicable
Conditions studied: Cytomegalovirus Retinitis, HIV Infections
In brief
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
Key facts
- Study ID
- NCT00002187
- Run by
- Ionis Pharmaceuticals, Inc.
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
- 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.
Where it is running
- Retina - Vitreous Associates Med Group — Los Angeles, California, United States
- Community Eye Med Group — Pasadena, California, United States
- Univ of California San Francisco / SF Gen Hosp — San Francisco, California, United States
- Dr Jacob Lalezari — San Francisco, California, United States
- Dr Alan Palestine — Washington D.C., District of Columbia, United States
- Dr Julio Perez — Fort Lauderdale, Florida, United States
- Georgia Retina — Atlanta, Georgia, United States
- Chicago Ctr for Clinical Research — Chicago, Illinois, United States
- Univ of Illinois — Chicago, Illinois, United States
- Indiana Univ Med Ctr — Indianapolis, Indiana, United States
- New York Univ Med Ctr — New York, New York, United States
- Vitreo - Retinal Consultants — New York, New York, United States
- Charlotte Eye Ear Nose & Throat Association — Charlotte, North Carolina, United States
- Duke Univ — Durham, North Carolina, United States
- Hahnemann Univ Hosp — Philadelphia, Pennsylvania, United States
- Baylor College of Medicine — Houston, Texas, United States
- Novum Inc — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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