A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
Cytomegalovirus Retinitis, HIV Infections
About this trial
This is an interventional treatment trial for Cytomegalovirus Retinitis focused on measuring AIDS-Related Opportunistic Infections, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, fomivirsen, Vitreous Body
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.
Sites / Locations
- Retina - Vitreous Associates Med Group
- Community Eye Med Group
- Univ of California San Francisco / SF Gen Hosp
- Dr Jacob Lalezari
- Dr Alan Palestine
- Dr Julio Perez
- Georgia Retina
- Chicago Ctr for Clinical Research
- Univ of Illinois
- Indiana Univ Med Ctr
- New York Univ Med Ctr
- Vitreo - Retinal Consultants
- Charlotte Eye Ear Nose & Throat Association
- Duke Univ
- Hahnemann Univ Hosp
- Baylor College of Medicine
- Novum Inc