A Randomized Comparison of Intravitreal ISIS 2922 Plus Ganciclovir Versus Ganciclovir as Treatment for Patients With Cytomegalovirus Retinitis ( CMVR )

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

To determine the clinically safe and effective dose of intravitreal ISIS 2922 alone and as an additive antiviral therapy to ganciclovir in AIDS patients with cytomegalovirus (CMV) retinitis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ionis Pharmaceuticals, Inc.
• Treatments: Fomivirsen; Ganciclovir; Ganciclovir triphosphate

Criteria

Inclusion Criteria

Patients must have:

• AIDS.

• CMV retinitis that is not adequately controlled (previously diagnosed patients with smoldering CMV retinitis or those with active CMV retinitis borders on indirect ophthalmoscopy).

• No more than one previous progression of CMV retinitis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions in the eye to be treated are excluded:

• External ocular infection.

• Other herpetic infections of the retina, toxoplasma retinochoroiditis, or other disease of the fundus.

• Ocular condition 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.

• Retinal pigment epithelial stippling not associated with CMV retinitis.

• Pseudoretinitis pigmentosa.

• Chronic diarrhea that would impair absorption of oral ganciclovir.

• Intolerance to ganciclovir.

Concurrent Medication:

Excluded:

• Foscarnet or other anti-CMV agents other than ganciclovir.

• 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 eye to be treated.

• History of intolerance to ISIS 2922.

Prior Medication:

Excluded:

• Prior ganciclovir implant for CMV retinitis.

• More than 4 months of prior ganciclovir.