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

Overview

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.

Full Title of Study: “A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: October 2009

Interventions

  • Drug: Macugen
    • Dosage form: solution for injection (intravitreal) Dosage: 0.3mg Frequency: every 6 weeks (9 injections/year)

Arms, Groups and Cohorts

  • 1
    • Patients who obtained reimbursement of Macugen.

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Secondary Measures

  • 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.
  • 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.
  • 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.
  • 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).
  • 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.
  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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