Neovascular Age-related Macular DegenerationMACURELINCT00549055
A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.
An observational study of Neovascular Age-related Macular Degeneration, run by Pfizer at 4 sites in Belgium.
Trial summary
To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- Macugen
- Type of treatment
- Injection or infusion
- How many people
- 38 participants
- Where
- 4 sitesBelgium
- Study dates
- Nov 2007to Oct 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.
Who may be able to join
- Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
- Patients having received at least 1 Macugen injection
- Treatment naive patients, or patients having received conventional therapy
- Patients having signed and dated informed consent.
Who cannot join
- Patients participating in another clinical study with Macugen.
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Pfizer Investigational Site
Aarschot, 3200
Pfizer Investigational Site
Deurne, 2100
Pfizer Investigational Site
Leuven, 3000
Pfizer Investigational Site
Liège, 4000
About this study
Official title: A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).
To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.
- Being tested
- Macugen
- Keywords
- Macugen Age-related macular degeneration (AMD) Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MacugenDrug
Also called Pegaptanib sodium
Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who obtained reimbursement of Macugen. Receives: Drug: Macugen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Final Visit in Visual Acuity (VA) Score
Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.
Measured: Baseline, Month 24 or Early Termination
Secondary outcomes (6)
Number of Participants With Change in VA: Improvement
Investigator's clinical judgement of Improvement in status of vision as compared to the previous Macugen injection, calculated from measurement of the difference between the VA scores at the 2 visits.
Measured: Months 3, 6, 9 and 12
Number of Participants With Change in VA: Stabilization
Investigator's clinical judgement as Stabilization in status of visual acuity as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.
Measured: Months 3, 6, 9 and 12
Number of Participants With Change in VA: Worsening
Investigator's clinical judgement as Worsening in status of vision as compared to the previous Macugen injection, determined from measurement difference between the VA scores at the 2 visits.
Measured: Months 3, 6, 9 and 12
Duration of Treatment
Duration of treatment per participant calculated as: date of injection (for the last injection of Macugen) minus date of injection (for the first injection of Macugen).
Measured: Baseline up to 28.4 months
Frequency of Macugen Administration
Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.
Measured: Baseline up to 28.4 months
Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments
Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).
Measured: Months 3, 6, 9 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2007 (estimated)
- Study startNov 2007
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Neovascular 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 38 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
- NCT00549055
- Sponsor's protocol ID
- A5751026
- Acronym
- MACURELI
- Status last verified
- Nov 2018
- First submitted
- 23 Oct 2007
- Last updated
- 6 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).
- ClinicalTrials.gov ID
- NCT00549055
- Acronym / sponsor ID
- MACURELI / A5751026
- Keywords
- Macugen Age-related macular degeneration (AMD) Observational study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 25 Oct 2007 (estimated)
- Results
- Posted 27 Oct 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: MacugenPatients who obtained reimbursement of Macugen. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.
Key inclusion criteria (4 listed)
- Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
- Patients having received at least 1 Macugen injection
- Treatment naive patients, or patients having received conventional therapy
- Patients having signed and dated informed consent.
Key exclusion criteria (1 listed)
- Patients participating in another clinical study with 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 |
|---|---|---|
| MacugenAlso: Pegaptanib sodiumDosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year) | Drug | 1 |
Primary outcome
Change From Baseline to Final Visit in Visual Acuity (VA) Score
Time frame: Baseline, Month 24 or Early Termination
Best corrected VA score, assessed on the scale over time (best corrected VA score at Final Visit minus best corrected VA score at Baseline). Lower scores represent poorer eyesight and higher scores represent better eyesight with a value of 1 representing normal eyesight. A positive change in score represents an improvement in sight.
6 secondary outcomes
Number of Participants With Change in VA: Improvement
Time frame: Months 3, 6, 9 and 12
Number of Participants With Change in VA: Stabilization
Time frame: Months 3, 6, 9 and 12
Number of Participants With Change in VA: Worsening
Time frame: Months 3, 6, 9 and 12
Duration of Treatment
Time frame: Baseline up to 28.4 months
Frequency of Macugen Administration
Time frame: Baseline up to 28.4 months
Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments
Time frame: Months 3, 6, 9 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Age-related Macular Degeneration, run by Pfizer at 4 sites in Belgium.
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 4 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 6 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline to Final Visit in Visual Acuity (VA) Score (time frame: Baseline, Month 24 or Early Termination). 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 6 Dec 2018.