Macular DegenerationPhase 3NCT00150202
Clinical Study Of EYE001 For Wet-Type AMD (Age-Related Macular Degeneration)
A Phase 3 study testing pegaptanib sodium in people with Macular Degeneration, run by Pfizer at 14 sites in Japan.
Trial summary
This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- pegaptanib sodium
- How many people
- 90 participants
- Where
- 14 sitesJapan
- Study dates
- Jul 2004to Oct 2006
- Phase
- Phase 3
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Wet AMD, Visual Acuity from 20/320 to 20/40
Who cannot join
- Diabetic retinopathy, laser coagulation history
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Pfizer Investigational Site
Fukuoka, Fukuoka, 812-8582
Pfizer Investigational Site
Fukushima, Fukushima, 960-1295
Pfizer Investigational Site
Kida-gun, Kagawa-ken, 761-0793
Pfizer Investigational Site
Kyoto, Kyoto, 606-8507
Pfizer Investigational Site
Maebashi, Gunma, 371-8511
Pfizer Investigational Site
Mitaka, Tokyo, 181-8611
Pfizer Investigational Site
Moriguchi, Osaka, 570-8506
Pfizer Investigational Site
Nagoya, Aichi-ken, 466-8560
Pfizer Investigational Site
Ōtsu, Shiga, 520-2192
Pfizer Investigational Site
Sapporo, Hokkaido, 060-8604
Pfizer Investigational Site
Shinjuku-ku, Tokyo, 160-8582
Pfizer Investigational Site
Suita, Osaka, 565-0871
Pfizer Investigational Site
Tokyo, Chiyoda-ku
Pfizer Investigational Site
Urayasu-shi, Chiba, 279-0021
About this study
Official title: Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.
- Conditions
- Macular Degeneration
- Being tested
- pegaptanib sodium
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegaptanib sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.
Secondary outcomes (1)
Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startJul 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 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
- NCT00150202
- Sponsor's protocol ID
- A5751010
- Status last verified
- Nov 2006
- First submitted
- 6 Sep 2005
- Last updated
- 7 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Of EYE001 In Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00150202
- Acronym / sponsor ID
- A5751010
- Conditions
- Macular Degeneration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 8 Sep 2005 (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.
This study will examine the efficacy and safety of pegaptanib sodium in Japanese patients with wet-type AMD, in order to establish that there is no large difference in the efficacy and the safety of the drug between Western and Japanese patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Wet AMD, Visual Acuity from 20/320 to 20/40
Key exclusion criteria (1 listed)
- Diabetic retinopathy, laser coagulation history
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 |
|---|---|---|
| pegaptanib sodium | Drug | – |
Primary outcome
Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.
1 secondary outcome
Safety profile of pegaptanib including side effects and lab test from the baseline to 54 weeks after the first treatment. Blood concentration of the drug from the baseline to 54 weeks after the irst treatment.
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 7 May 2007.
Related trials for Macular Degeneration
RecruitingPhase 3
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Neovascular Age-related Macular Degeneration
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Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
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Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
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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
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing pegaptanib sodium in people with Macular Degeneration, run by Pfizer at 14 sites in Japan.
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 1 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: finished, as of the sponsor's last update on 7 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Japan. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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.
What does the primary outcome measure?
Visual aquity change from the baseline to 54 weeks after the first treatment is expected to be similar to that seen in the Western studies.. 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 7 May 2007.