Age-Related Macular DegenerationPhase 1/2NCT00090532
A Study Of The Safety And Efficacy Of AG-013,958 In Subjects With Subfoveal Choroidal Neovascularization Associated With Age-Related Macular Degeneration
A Phase 1/2 study testing AG-013,958 in people with Age-Related Macular Degeneration, run by Pfizer at 39 sites in 4 countries.
Trial summary
AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with "wet" age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- AG-013,958
- How many people
- 155 participants
- Where
- 39 sitesin 4 countries
- Study dates
- Jan 2004to Aug 2006
- Phase
- Phase 1/2
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and/or female subjects >=55 years of age
- Subfoveal choroidal neovascularization complicating age-related macular degeneration
- Subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent in accordance with institutional and regulatory guidelines
Who cannot join
- Other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year
Trial locations and contacts
39 sites in 4 countries.
39 sites in 4 countries
United States30 sites
Pfizer Investigational Site
Ann Arbor, Michigan
Pfizer Investigational Site
Beverly Hills, California
Pfizer Investigational Site
Boston, Massachusetts
Pfizer Investigational Site
Chambersburg, Pennsylvania
Pfizer Investigational Site
Charlotte, North Carolina
Pfizer Investigational Site
Chevy Chase, Maryland
Pfizer Investigational Site
Cleveland, Ohio
Pfizer Investigational Site
Columbia, South Carolina
Pfizer Investigational Site
Fairfax, Virginia
Pfizer Investigational Site
Fort Myers, Florida
Pfizer Investigational Site
Hagerstown, Maryland
Pfizer Investigational Site
Houston, Texas
Pfizer Investigational Site
Huntersville, North Carolina
Pfizer Investigational Site
Iowa City, Iowa
Pfizer Investigational Site
Knoxville, Tennessee
Pfizer Investigational Site
Lakewood, Ohio
Pfizer Investigational Site
Livonia, Michigan
Pfizer Investigational Site
Mesa, Arizona
Pfizer Investigational Site
Oro Valley, Arizona
Pfizer Investigational Site
Phoenix, Arizona
Pfizer Investigational Site
Portland, Oregon
Pfizer Investigational Site
Rochester, Michigan
Pfizer Investigational Site
Royal Oak, Michigan
Pfizer Investigational Site
Saint Clair Shores, Michigan
Pfizer Investigational Site
Slingerlands, New York
Pfizer Investigational Site
Sun City, Arizona
Pfizer Investigational Site
Tampa, Florida
Pfizer Investigational Site
Tucson, Arizona
Pfizer Investigational Site
Tuscon, Arizona
Pfizer Investigational Site
Ypsilanti, Michigan
Netherlands4 sites
Pfizer Investigational Site
Amsterdam, North Holland
Pfizer Investigational Site
Groningen, Provincie Groningen
Pfizer Investigational Site
Nijmegen, Gelderland
Pfizer Investigational Site
Rotterdam, South Holland
United Kingdom3 sites
Pfizer Investigational Site
Aberdeen, Scotland
Pfizer Investigational Site
Bristol
Pfizer Investigational Site
London
Australia2 sites
Pfizer Investigational Site
East Melbourne, Victoria
Pfizer Investigational Site
Sydney, New South Wales
About this study
Official title: A Phase 1/2, Randomized, Masked, Single and Multiple-Dose, Sequential Dose-Escalation Study of the Safety an Efficacy of AG-013958 in Subjects With Subfoveal Choroidal Neovascularization Associated With Age-related Macular Degeneration
AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with "wet" age-related macular degeneration.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- AG-013,958
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AG-013,958Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the ocular and systemic safety of the study drug
Secondary outcomes (1)
To evaluate the visual acuity change after study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2004 (estimated)
- Study startJan 2004
- Study completionAug 2006
Why it stopped: This study was terminated due to a lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 155 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00090532
- Sponsor's protocol ID
- A4321001
- Status last verified
- May 2011
- First submitted
- 26 Aug 2004
- Last updated
- 27 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Randomized, Masked, Single and Multiple-Dose, Sequential Dose-Escalation Study of the Safety an Efficacy of AG-013958 in Subjects With Subfoveal Choroidal Neovascularization Associated With Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00090532
- Acronym / sponsor ID
- A4321001
- Conditions
- Age-Related Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to a lack of efficacy.
- Enrolment
- 155 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 31 Aug 2004 (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.
AG-013,958 is being studied to treat patients with Age-Related Macular Degeneration. A total of 144 subjects may be enrolled in the trial. Subjects will be male or female at least 55 years of age with "wet" age-related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and/or female subjects >=55 years of age
- Subfoveal choroidal neovascularization complicating age-related macular degeneration
- Subjects who are informed of, and willing and able to comply with, the investigational nature of the study and are able to provide written informed consent in accordance with institutional and regulatory guidelines
Key exclusion criteria (1 listed)
- Other serious ocular diseases or conditions, including diabetic retinopathy and glaucoma, that are likely to compromise visual acuity within 1 year
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 |
|---|---|---|
| AG-013,958 | Drug | – |
Primary outcome
To evaluate the ocular and systemic safety of the study drug
1 secondary outcome
To evaluate the visual acuity change after study treatment
Results and safety
The study was stopped early (reason given: This study was terminated due to a lack of efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
39 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AG-013,958 in people with Age-Related Macular Degeneration, run by Pfizer at 39 sites in 4 countries.
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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 27 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Netherlands, United Kingdom, Australia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated due to a lack of efficacy.). Results are not available in the source record.
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.
What does the primary outcome measure?
To evaluate the ocular and systemic safety of the study drug. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2011.