Completed

Intravitreal ISIS 2922 for Peripheral CMV Retinitis: Immediate vs Delayed Treatment

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What is being tested

Fomivirsen sodium

Drug
Who is being recruted

Blood-Borne Infections+24

+ Urogenital Diseases

+ Genital Diseases

Over 18 Years
+26 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
See protocol details

Summary

Principal SponsorIonis Pharmaceuticals, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

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.

NCT00002355
Principal SponsorIonis Pharmaceuticals, Inc.
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

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

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesGenital DiseasesCommunicable DiseasesCytomegalovirus InfectionsDNA Virus InfectionsEye DiseasesHerpesviridae InfectionsImmunologic Deficiency SyndromesImmune System DiseasesInfectionsOpportunistic InfectionsRetinal DiseasesRetinitisRetroviridae InfectionsRNA Virus InfectionsSexually Transmitted DiseasesSlow Virus DiseasesVirus DiseasesSexually Transmitted Diseases, ViralEye InfectionsEye Infections, ViralLentivirus InfectionsAcquired Immunodeficiency SyndromeHIV InfectionsAIDS-Related Opportunistic InfectionsCytomegalovirus Retinitis

Criteria

4 inclusion criteria required to participate
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
22 exclusion criteria prevent from participating
Anti-CMV therapy for extra-ocular infection within the past 2 days
Clofazimine
Current treatment for extra-ocular CMV infection
Ethambutol/fluconazole combination
Show More Criteria

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Retina - Vitreous Associates Med Group

Los Angeles, United StatesOpen Retina - Vitreous Associates Med Group in Google Maps

Community Eye Med Group

Pasadena, United States

Santa Clara Valley Med Ctr

San Jose, United States

Univ of Colorado Health Sciences Ctr

Denver, United States
Completed13 Study Centers