Cytomegalovirus RetinitisNCT00002187
A Study of ISIS 2922 in the Treatment of Advanced Cytomegalovirus Retinitis
A study testing Fomivirsen sodium in people with Cytomegalovirus Retinitis and HIV Infections, run by Ionis Pharmaceuticals, Inc. at 17 sites in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Retinitis, HIV Infections
- What is being tested?
- Fomivirsen sodium
- How many people
- Not given
- Where
- 17 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Concurrent Medication:
- Allowed:
- Oral ganciclovir.
- Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.
- Patients must have:
- Documented AIDS.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Georgia Retina
Atlanta, Georgia, 30327
Charlotte Eye Ear Nose & Throat Association
Charlotte, North Carolina, 28204
Chicago Ctr for Clinical Research
Chicago, Illinois, 60610
Univ of Illinois
Chicago, Illinois, 60612
Duke Univ
Durham, North Carolina, 27710
Dr Julio Perez
Fort Lauderdale, Florida, 33060
Baylor College of Medicine
Houston, Texas, 77030
Indiana Univ Med Ctr
Indianapolis, Indiana, 46202
Retina - Vitreous Associates Med Group
Los Angeles, California, 90017
New York Univ Med Ctr
New York, New York, 10016
Vitreo - Retinal Consultants
New York, New York, 10028
Community Eye Med Group
Pasadena, California, 911052536
Hahnemann Univ Hosp
Philadelphia, Pennsylvania, 191021192
Univ of California San Francisco / SF Gen Hosp
San Francisco, California, 94110
Dr Jacob Lalezari
San Francisco, California, 94115
Novum Inc
Seattle, Washington, 98104
Dr Alan Palestine
Washington D.C., District of Columbia, 20006
About this study
Official title: A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis
The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis
Read the detailed description
This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Being tested
- Fomivirsen sodium
- Keywords
- AIDS-Related Opportunistic Infections, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, fomivirsen, Vitreous Body
- Medical subject headings
- Cytomegalovirus Retinitis, HIV Infections, AIDS-Related Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fomivirsen sodiumDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus RetinitisStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00002187
- Sponsor's protocol ID
- 251D
- Other IDs
- ISIS 2922-CS9
- Status last verified
- Dec 1998
- First submitted
- 2 Nov 1999
- Last updated
- 24 Jun 2005
- Results posted
- No
Publications
New CMV drug won't replace other therapies. AIDS Alert. 1998 Nov;13(11):124-6.
PubMed 11365968Roehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6.
PubMed 11365956
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Comparison of Two Dosage Schedules of Intravitreal ISIS 2922 for Patients With Advanced Cytomegalovirus Retinitis
- ClinicalTrials.gov ID
- NCT00002187
- Acronym / sponsor ID
- 251D
- Conditions
- Cytomegalovirus Retinitis, HIV Infections
- Keywords
- AIDS-Related Opportunistic Infections, Antiviral Agents, Drug Administration Schedule, Cytomegalovirus Retinitis, fomivirsen, Vitreous Body
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the safety and effectiveness of two dosage schedules for ISIS 2922 in the treatment of advanced cytomegalovirus (CMV) retinitis
Detailed description
This is a multicenter, prospective, randomized, open-label study comparing 2 dosage schedules of ISIS 2922.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Oral ganciclovir.
- Leukocyte growth factors (GM-CSF and G-CSF) for patients with febrile neutropenia.
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fomivirsen sodium | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2005.
- Background: PubMed 11365968New CMV drug won't replace other therapies. AIDS Alert. 1998 Nov;13(11):124-6.
- Background: PubMed 11365956Roehr B. Fomivirsen approved for CMV retinitis. J Int Assoc Physicians AIDS Care. 1998 Oct;4(10):14-6.
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Clinical Study of High Concentration Ganciclovir Eye Drops in the Treatment of Cytomegalovirus Retinitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fomivirsen sodium in people with Cytomegalovirus Retinitis and HIV Infections, run by Ionis Pharmaceuticals, Inc. at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00002187, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2005.