A Comparison of ISIS 2922 Used Immediately or Later in Patients With Cytomegalovirus (CMV) of the Eyes
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Purpose
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 | Intervention |
|---|---|
|
Cytomegalovirus Retinitis HIV Infections |
Drug: Fomivirsen sodium |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Primary Purpose: Treatment |
| Official Title: | A Randomized Comparison of Immediate Versus Delayed Treatment With Intravitreal Injections of ISIS 2922 in Patients With Peripheral Cytomegalovirus (CMV) Retinitis |
| Estimated 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, California | |
| Retina - Vitreous Associates Med Group | |
| Los Angeles, California, United States, 90017 | |
| Community Eye Med Group | |
| Pasadena, California, United States, 911052536 | |
| Santa Clara Valley Med Ctr | |
| San Jose, California, United States, 95128 | |
| United States, Colorado | |
| Univ of Colorado Health Sciences Ctr | |
| Denver, Colorado, United States, 80262 | |
| United States, Florida | |
| Dr Julio Perez | |
| Fort Lauderdale, Florida, United States, 33060 | |
| United States, Georgia | |
| Georgia Retina | |
| Atlanta, Georgia, United States, 30327 | |
| United States, Illinois | |
| Univ of Illinois | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Indiana Univ Med Ctr | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, New York | |
| Vitreo - Retinal Consultants | |
| New York, New York, United States, 10028 | |
| United States, North Carolina | |
| Charlotte Eye Ear Nose & Throat Association | |
| Charlotte, North Carolina, United States, 28204 | |
| United States, Texas | |
| Univ of Texas Southwestern Med Ctr of Dallas | |
| Dallas, Texas, United States, 752359057 | |
| United States, Virginia | |
| Virginia Eye Consultants | |
| Norfolk, Virginia, United States, 23507 | |
| United States, Washington | |
| Novum Inc | |
| Seattle, Washington, United States, 98104 | |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00002355 History of Changes |
| Other Study ID Numbers: | 251A, ISIS 2922-CS2 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
AIDS-Related Opportunistic Infections Acquired Immunodeficiency Syndrome Antiviral Agents Cytomegalovirus Retinitis |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Retinitis Cytomegalovirus Retinitis Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
Retinal Diseases Eye Diseases Cytomegalovirus Infections Herpesviridae Infections DNA Virus Infections Eye Infections, Viral Eye Infections Fomivirsen Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013