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

Pfizer108 enrolled

Overview

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.

no sampling

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

Age-related Macular Degeneration

Interventions

no interventionOTHER

Outpatients with age-related macular degeneration (AMD)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (11)

Pfizer Investigational Site

Brno, Czechia

Pfizer Investigational Site

Brno, Czechia

Pfizer Investigational Site

Olomouc, Czechia

Pfizer Investigational Site

Outcomes

Primary Outcomes

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

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.

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

Secondary Outcomes

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

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.

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

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

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.

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

Data from ClinicalTrials.gov

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