A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life. (MACURELI)

November 6, 2018 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

38

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aarschot, Belgium, 3200
        • Pfizer Investigational Site
      • Deurne, Belgium, 2100
        • Pfizer Investigational Site
      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Liege, Belgium, 4000
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients participating in another clinical study with Macugen.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Patients who obtained reimbursement of Macugen.
Drug: Macugen
Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
Other Names:
  • Pegaptanib sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 24 or Early Termination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Change in VA: Improvement
Time Frame: Months 3, 6, 9 and 12
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.
Months 3, 6, 9 and 12
Number of Participants With Change in VA: Stabilization
Time Frame: Months 3, 6, 9 and 12
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.
Months 3, 6, 9 and 12
Number of Participants With Change in VA: Worsening
Time Frame: Months 3, 6, 9 and 12
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.
Months 3, 6, 9 and 12
Duration of Treatment
Time Frame: Baseline up to 28.4 months
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).
Baseline up to 28.4 months
Frequency of Macugen Administration
Time Frame: Baseline up to 28.4 months
Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.
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
Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).
Months 3, 6, 9 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

October 23, 2007

First Submitted That Met QC Criteria

October 23, 2007

First Posted (Estimate)

October 25, 2007

Study Record Updates

Last Update Posted (Actual)

December 6, 2018

Last Update Submitted That Met QC Criteria

November 6, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A5751026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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