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.

Condition	Treatment or Intervention
Cytomegalovirus Retinitis HIV Infections	Drug: Fomivirsen sodium

Further Study Details: 

Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

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.

California
      Santa Clara Valley Med Ctr, San Jose,  California,  95128,  United States
      Community Eye Med Group, Pasadena,  California,  911052536,  United States
      Retina - Vitreous Associates Med Group, Los Angeles,  California,  90017,  United States
Colorado
      Univ of Colorado Health Sciences Ctr, Denver,  Colorado,  80262,  United States
Florida
      Dr Julio Perez, Fort Lauderdale,  Florida,  33060,  United States
Georgia
      Georgia Retina, Atlanta,  Georgia,  30327,  United States
Illinois
      Univ of Illinois, Chicago,  Illinois,  60612,  United States
Indiana
      Indiana Univ Med Ctr, Indianapolis,  Indiana,  46202,  United States
New York
      Vitreo - Retinal Consultants, New York,  New York,  10028,  United States
North Carolina
      Charlotte Eye Ear Nose & Throat Association, Charlotte,  North Carolina,  28204,  United States
Texas
      Univ of Texas Southwestern Med Ctr of Dallas, Dallas,  Texas,  752359057,  United States
Virginia
      Virginia Eye Consultants, Norfolk,  Virginia,  23507,  United States
Washington
      Novum Inc, Seattle,  Washington,  98104,  United States

Study ID Numbers:  251A; ISIS 2922-CS2
Record last reviewed:  July 1998
Last Updated:  October 13, 2004
Record first received:  November 2, 1999
ClinicalTrials.gov Identifier:  NCT00002355
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08