Macular DegenerationNCT00845273
Long-Term Use Of Pegaptanib In Patients For Subfoveal Choroidal Neovascularization Secondary To Age-Related Macular Degeneration
An observational study of Macular Degeneration, run by Pfizer.
Trial summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- Pegaptanib sodium
- Type of treatment
- Injection or infusion
- How many people
- 3,538 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Feb 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an investigator involving A5751033 prescribes the Macugen®).
Who may be able to join
- Patients need to be administered Macugen® in order to be enrolled in the surveillance.
Who cannot join
- Patients not administered Macugen®.
About this study
Official title: Special Investigation For Long-term Use Of Macugen (Regulatory Post Marketing Commitment Plan).
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Read the detailed description
All the patients whom an investigator prescribes the first Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
- Conditions
- Macular Degeneration
- Being tested
- Pegaptanib sodium
- Keywords
- Subfoveal choroidal neovascularization secondary to age-related macular degeneration
- 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
Also called Macugen
Macugen Intravitreous Injection Kit 0.3mg depending on the Investigator prescription.
Frequency and duration are according to Package Insert as follows. "Pegaptanib sodium is administered intravitreously once every 6 weeks at a dose level of 0.3 mg (on an oligonucleotide of pegaptanib basis )".
| Study group | Role | What they receive |
|---|---|---|
| Pegaptanib sodium | Patients administered Pegaptanib sodium. Receives: Drug: Pegaptanib sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Factors considered to affect the safety and/or efficacy of this drug.
Measured: 2 years
The incidence of adverse drug reactions in this surveillance.
Measured: 2 years
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2014
- Study completionFeb 2014
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 3,538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845273
- Sponsor's protocol ID
- A5751033
- Status last verified
- Sep 2015
- First submitted
- 9 Dec 2008
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Investigation For Long-term Use Of Macugen (Regulatory Post Marketing Commitment Plan).
- ClinicalTrials.gov ID
- NCT00845273
- Acronym / sponsor ID
- A5751033
- Conditions
- Macular Degeneration
- Keywords
- Subfoveal choroidal neovascularization secondary to age-related macular degeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,538 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Feb 2009 (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 objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3) factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes the first Macugen® should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pegaptanib sodium | – | Drug: Pegaptanib sodiumPatients administered Pegaptanib sodium. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an investigator involving A5751033 prescribes the Macugen®).
Key inclusion criteria (1 listed)
- Patients need to be administered Macugen® in order to be enrolled in the surveillance.
Key exclusion criteria (1 listed)
- Patients not administered Macugen®.
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 sodiumAlso: MacugenMacugen Intravitreous Injection Kit 0.3mg depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. "Pegaptanib sodium is administered intravitreously once every 6 weeks at a dose level of 0.3 mg (on an oligonucleotide of pegaptanib basis )". | Drug | Pegaptanib sodium |
Primary outcome
Factors considered to affect the safety and/or efficacy of this drug.
Time frame: 2 years
The incidence of adverse drug reactions in this surveillance.
Time frame: 2 years
Adverse drug reaction not expected from the LPD (unknown adverse drug reaction).
Time frame: 2 years
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 2 Oct 2015.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Degeneration, run by Pfizer.
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 2 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Factors considered to affect the safety and/or efficacy of this drug. (time frame: 2 years). The study lists 3 primary outcomes in all. 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 2 Oct 2015.