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

Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787319
• Other study ID #: A5751032
• Status: Completed
• Start date: January 2010
• Est. completion date: June 2012

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

no sampling

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration
• Wet Macular Degeneration

Intervention

Other:
• no intervention
Outpatients with age-related macular degeneration (AMD)

Locations

Country	Name	City	State
Czechia	Pfizer Investigational Site	Brno
Czechia	Pfizer Investigational Site	Brno
Czechia	Pfizer Investigational Site	Olomouc
Czechia	Pfizer Investigational Site	Olomouc
Czechia	Pfizer Investigational Site	Ostrava - Poruba
Czechia	Pfizer Investigational Site	Plzen
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 6
Czechia	Pfizer Investigational Site	Praha 6
Czechia	Pfizer Investigational Site	Usti nad Labem

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring	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.	Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
Other	Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Baseline up to Week 104 (EOS)
Other	Duration of Treatment	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.	Baseline up to Week 104 (EOS)
Other	Mean Number of Doses of Study Medication Received		Baseline up to Week 104 (EOS)
Other	Physician's Assessment of Tolerability	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.	Baseline up to Week 104 (EOS)
Primary	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.	Baseline, Final Visit (Week 104 or early termination [ET])
Secondary	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.	Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
Secondary	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.	Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
Secondary	Physician's Assessment of Efficacy	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.	Week 104 or End of study (EOS)

External Links

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