Clinical trial NCT00002355: A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
Official title: A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Acquired Immunodeficiency Syndrome
Antiviral Agents
Cytomegalovirus Retinitis
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Retina - Vitreous Associates Med Group
state: California
city: Pasadena
country: United States
facility: Community Eye Med Group
state: California
city: San Jose
country: United States
facility: Santa Clara Valley Med Ctr
state: California
city: Denver
country: United States
facility: Univ of Colorado Health Sciences Ctr
state: Colorado
city: Fort Lauderdale
country: United States
facility: Dr Julio Perez
state: Florida
city: Atlanta
country: United States
facility: Georgia Retina
state: Georgia
city: Chicago
country: United States
facility: Univ of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Indiana Univ Med Ctr
state: Indiana
city: New York
country: United States
facility: Vitreo - Retinal Consultants
state: New York
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose & Throat Association
state: North Carolina
city: Dallas
country: United States
facility: Univ of Texas Southwestern Med Ctr of Dallas
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Seattle
country: United States
facility: Novum Inc
state: Washington
Study officials:
References: