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

NCT ID: NCT00002355

Last Updated: 2005-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cytomegalovirus Retinitis HIV Infections

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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Fomivirsen sodium

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ionis Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Locations

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Retina - Vitreous Associates Med Group

Los Angeles, California, United States

Site Status

Community Eye Med Group

Pasadena, California, United States

Site Status

Santa Clara Valley Med Ctr

San Jose, California, United States

Site Status

Univ of Colorado Health Sciences Ctr

Denver, Colorado, United States

Site Status

Dr Julio Perez

Fort Lauderdale, Florida, United States

Site Status

Georgia Retina

Atlanta, Georgia, United States

Site Status

Univ of Illinois

Chicago, Illinois, United States

Site Status

Indiana Univ Med Ctr

Indianapolis, Indiana, United States

Site Status

Vitreo - Retinal Consultants

New York, New York, United States

Site Status

Charlotte Eye Ear Nose & Throat Association

Charlotte, North Carolina, United States

Site Status

Univ of Texas Southwestern Med Ctr of Dallas

Dallas, Texas, United States

Site Status

Virginia Eye Consultants

Norfolk, Virginia, United States

Site Status

Novum Inc

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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ISIS 2922-CS2

Identifier Type: -

Identifier Source: secondary_id

251A

Identifier Type: -

Identifier Source: org_study_id