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Completed

NCT Number: NCT00549055

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

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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Key information

Conditions

Neovascular Age-related Macular Degeneration

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Aarschot, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Macugen

Drug

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

Other names: Pegaptanib sodium

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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.

  6. 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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Acronym: MACURELI

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 25, 2007
Registry last updated
Dec 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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