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

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Other: no intervention

• Registration Number: NCT00787319
• Lead Sponsor: Pfizer

Brief Summary

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.

Detailed Description

no sampling

Study Timeline

• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Study Start: 2010-01
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2013-05-15
• Results First Submitted QC: 2013-05-15
• Results First Posted: 2013-08-13
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-06
• Last Update Posted: 2018-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AMD	no intervention	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Visual Acuity (VA) at Final Visit	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 Outcome Measures

Name	Time	Method
Physician's Assessment of Efficacy	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.
Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination	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.
Change From Baseline in Visual Acuity (VA) at Each Visit	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇿 Usti nad Labem, Czechia