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

Sponsor

Ionis Pharmaceuticals, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00002355

Collaborator

(none)

Enrollment

Locations

4.6

Patients Per Site

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cytomegalovirus Retinitis HIV Infections	Drug: Fomivirsen sodium	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Primary Purpose:

Treatment

Official Title:

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

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 0 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Retina - Vitreous Associates Med Group	Los Angeles	California	United States	90017
2	Community Eye Med Group	Pasadena	California	United States	911052536
3	Santa Clara Valley Med Ctr	San Jose	California	United States	95128
4	Univ of Colorado Health Sciences Ctr	Denver	Colorado	United States	80262
5	Dr Julio Perez	Fort Lauderdale	Florida	United States	33060
6	Georgia Retina	Atlanta	Georgia	United States	30327
7	Univ of Illinois	Chicago	Illinois	United States	60612
8	Indiana Univ Med Ctr	Indianapolis	Indiana	United States	46202
9	Vitreo - Retinal Consultants	New York	New York	United States	10028
10	Charlotte Eye Ear Nose & Throat Association	Charlotte	North Carolina	United States	28204
11	Univ of Texas Southwestern Med Ctr of Dallas	Dallas	Texas	United States	752359057
12	Virginia Eye Consultants	Norfolk	Virginia	United States	23507
13	Novum Inc	Seattle	Washington	United States	98104