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OpenTrials
Completed

NCT Number: NCT00787319

Long-Term Non-Interventional Study (NIS) To Investigate The Safety And Effectiveness Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice

To define what procedures were used for the diagnosis and monitoring of the treatment age-related macular degeneration (AMD). What is the effect of the Macugen, compliance with Macugen treatment, safety profile of Macugen, final physician assessment of treatment with Macugen.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer Investigational Site, Brno, Czechia

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About this study

no sampling

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age over 18 years old
  • patients with neovascular age-related macular degeneration
  • enrollment to study is fully on physician decision in compliance with current SPC

Exclusion criteria

  • Patient who did not meet indication according to SPC Macugen.

Treatment and study plan

No intervention

Other

Outpatients with age-related macular degeneration (AMD)

Other names: observation only

Primary outcomes

  1. Change From Baseline in Visual Acuity (VA) at Final Visit

    Time frame: Baseline, Final Visit (Week 104 or early termination [ET])

    Visual acuity (VA) measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as Logarithm of Minimum Angle of Resolution (logMAR), logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.

Secondary outcomes

  1. Change From Baseline in Visual Acuity (VA) at Each Visit

    Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

    VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. Decimal VA data presented as logMAR, logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss, while negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts (85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results were based on study eye for which medication was given.

  2. Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination

    Time frame: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

    VA measured as viewing distance (distance for participant/distance for normal vision). Viewing distance considered as fraction to calculate decimal VA. logMAR= -log10 (decimal VA). It measures VA loss; positive values indicated vision loss,negative values denote normal/better VA and allowed comparison of data using different viewing distances and/or different charts(85 or 100 letters, 85 letter equivalents to decimal VA of 1.0). Results based on study eye for which medication was given. Number of participants with VA improved, unchanged or worsened as compared to previous examination reported.

  3. Physician's Assessment of Efficacy

    Time frame: Week 104 or End of study (EOS)

    Efficacy was based on the study eye for which pegaptanib treatment was given. Number of participants with each grade of efficacy of treatment, as assessed by the physician was reported on the 5 point categorical scale: excellent, very good, good, fair, poor.

Other outcomes

  1. Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring

    Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102

    Procedures used for diagnosis of AMD and monitoring of the course of treatment included fluorescein angiography (FA), optical coherent tomography (OCT), or other (Ot) procedure apart from FA and OCT. OCT, FA, and other are not mutually exclusive, hence same participant may be included in more than 1 procedure for AMD diagnosis and monitoring at a particular time point.

  2. Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)

    Time frame: Baseline up to Week 104 (EOS)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  3. Duration of Treatment

    Time frame: Baseline up to Week 104 (EOS)

    Duration of treatment (in weeks) was calculated as: (date of the last injection of study medication minus date of the first injection of study medication plus 1) divided by 7.

  4. Mean Number of Doses of Study Medication Received

    Time frame: Baseline up to Week 104 (EOS)

  5. Physician's Assessment of Tolerability

    Time frame: Baseline up to Week 104 (EOS)

    Number of participants with each grade of tolerability of treatment as assessed by physician was evaluated on the five point categorical scale: excellent, very good, good, fair, poor.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 7, 2008
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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