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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002355
• Other study ID #: 251A
• Secondary ID: ISIS 2922-CS2
• Status: Completed
• Phase: N/A
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: July 1998
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cytomegalovirus Retinitis
• HIV Infections
• Retinitis

Intervention

Drug:
• Fomivirsen sodium

Locations

Country	Name	City	State
United States	Georgia Retina	Atlanta	Georgia
United States	Charlotte Eye Ear Nose & Throat Association	Charlotte	North Carolina
United States	Univ of Illinois	Chicago	Illinois
United States	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas
United States	Univ of Colorado Health Sciences Ctr	Denver	Colorado
United States	Dr Julio Perez	Fort Lauderdale	Florida
United States	Indiana Univ Med Ctr	Indianapolis	Indiana
United States	Retina - Vitreous Associates Med Group	Los Angeles	California
United States	Vitreo - Retinal Consultants	New York	New York
United States	Virginia Eye Consultants	Norfolk	Virginia
United States	Community Eye Med Group	Pasadena	California
United States	Santa Clara Valley Med Ctr	San Jose	California
United States	Novum Inc	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,