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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
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* Drug: Fomivirsen sodium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fomivirsen sodium|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AIDS-Related Opportunistic Infections, Acquired Immunodeficiency Syndrome, Antiviral Agents, Cytomegalovirus Retinitis