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

October 23, 2007
February 15, 2011
November 2007
October 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00549055 on ClinicalTrials.gov Archive Site
  • 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).
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A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.
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.

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Observational
Observational Model: Cohort
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Probability Sample

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

Exudative Age-related Macular Degeneration
Drug: Macugen
Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)
Other Name: Pegaptanib sodium
1
Patients who obtained reimbursement of Macugen.
Intervention: Drug: Macugen
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
October 2009
October 2009   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00549055
A5751026
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP