Clinical trial NCT00002187: A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Official title: A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cytomegalovirus Retinitis
HIV Infections
Keywords: AIDS-Related Opportunistic Infections
Antiviral Agents
Drug Administration Schedule
Cytomegalovirus Retinitis
fomivirsen
Vitreous Body
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis

Detailed description: This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Oral ganciclovir.
* Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.

Patients must have:

* Documented AIDS.
* Clinical diagnosis of advanced CMV retinitis in 1 or both eyes.
* \>= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.
* \> 25% retinal involvement with CMV retinitis.
* Baseline CMV retinitis lesions which have leading edges \> 1000 micrograms from the macula or optic disk.

Prior Medication:

Required:

* \>= 2 previous induction courses with anti-CMV retinitis therapy licensed by a regulatory agency.

Allowed:

* All anti-CMV therapies other than ganciclovir must be discontinued no less than 2 days prior to entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms and conditions are excluded:

* External ocular infection in the eye to be treated.
* Other herpetic infections of the retina, toxoplasma, retinochoroiditis, or other disease of the fundus that would preclude assessment of CMV retinitis in the eye to be treated.
* Ocular conditions that will obstruct visualization of the posterior ocular structures on the eye to be treated.
* Retinal detachment in the eye to be treated.
* Ganciclovir implant in the eye to be treated.
* Known or suspected allergy to phosphorothioate oligonucleotides or intolerance of ISIS 2922.
* Silicone oil in the eye to be treated.
* Pseudoretinitis pigmentosa.
* Syphilis.

Patients with the following prior conditions are excluded:

* History of surgery to correct retinal detachment in the eye to be treated.
* History of syphilis.

  1. Systemic anti-CMV therapies other than oral ganciclovir.
* Mellaril, Stelazine, chlorpromazine and clofazimine.
* Combination use of ethambutol and fluconazole.
* Investigational medications and/or procedures for the treatment of CMV retinitis in the eye to be treated.
* Ganciclovir implant delivery device in the eye to be treated.
* Ganciclovir other than oral.
* Foscarnet.

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 Francisco
country: United States
facility: Univ of California San Francisco / SF Gen Hosp
state: California
city: San Francisco
country: United States
facility: Dr Jacob Lalezari
state: California
city: Washington
country: United States
facility: Dr Alan Palestine
state: District of Columbia
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: Chicago Ctr for Clinical Research
state: Illinois
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: New York Univ Med Ctr
state: New York
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: Durham
country: United States
facility: Duke Univ
state: North Carolina
city: Philadelphia
country: United States
facility: Hahnemann Univ Hosp
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Seattle
country: United States
facility: Novum Inc
state: Washington
Study officials:
References:
citation: New CMV drug won't replace other therapies. AIDS Alert. 1998 Nov;13(11):124-6.
citation: Roehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6.