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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00549055
First received: October 23, 2007
Last updated: February 15, 2011
Last verified: February 2011
  Purpose

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.


Condition Intervention
Exudative Age-related Macular Degeneration
Drug: Macugen

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline to Final Visit in Visual Acuity (VA) Score [ Time Frame: Baseline, Month 24 or Early Termination ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of Participants With Change in VA: Improvement [ Time Frame: Months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Change in VA: Stabilization [ Time Frame: Months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Change in VA: Worsening [ Time Frame: Months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    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.

  • Duration of Treatment [ Time Frame: Baseline up to 28.4 months ] [ Designated as safety issue: No ]
    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).

  • Frequency of Macugen Administration [ Time Frame: Baseline up to 28.4 months ] [ Designated as safety issue: No ]
    Average frequency of Macugen administration per participant calculated as: (number of Macugen injections administered per participant - 1)/ duration of treatment.

  • Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments [ Time Frame: Months 3, 6, 9 and 12 ] [ Designated as safety issue: No ]
    Derived by whether a participant took any other AMD treatments at any time (at any Study Treatment Visit).


Enrollment: 38
Study Start Date: November 2007
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: Pegaptanib sodium

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00549055

Locations
Belgium
Pfizer Investigational Site
Aarschot, Belgium, 3200
Pfizer Investigational Site
Deurne, Belgium, 2100
Pfizer Investigational Site
Leuven, Belgium, 3000
Pfizer Investigational Site
Liege, Belgium, 4000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00549055     History of Changes
Other Study ID Numbers: A5751026
Study First Received: October 23, 2007
Results First Received: October 1, 2010
Last Updated: February 15, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by Pfizer:
Macugen Age-related macular degeneration (AMD) Observational study

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014