Clinical trial 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Keywords: Ophthalmology
Age-related macular degeneration
outpatients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: outpatients

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Visual Acuity (VA) at Final Visit
timeFrame: Baseline, Final Visit (Week 104 or early termination [ET])
Secondary outcomes:
measure: Change From Baseline in Visual Acuity (VA) at Each Visit
timeFrame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
measure: Number of Participants With Change in Visual Acuity (VA) as Compared to Previous Examination
timeFrame: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
measure: Physician's Assessment of Efficacy
timeFrame: Week 104 or End of study (EOS)
Other outcomes:
measure: Number of Participants With Procedures for Age-related Macular Degeneration (AMD) Diagnosis and Monitoring
timeFrame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
measure: Number of Participants Who Discontinued Treatment Due to Adverse Events (AEs)
timeFrame: Baseline up to Week 104 (EOS)
measure: Duration of Treatment
timeFrame: Baseline up to Week 104 (EOS)
measure: Mean Number of Doses of Study Medication Received
timeFrame: Baseline up to Week 104 (EOS)
measure: Physician's Assessment of Tolerability
timeFrame: Baseline up to Week 104 (EOS)
Locations:
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Brno
country: Czechia
facility: Pfizer Investigational Site
city: Olomouc
country: Czechia
facility: Pfizer Investigational Site
city: Olomouc
country: Czechia
facility: Pfizer Investigational Site
city: Ostrava - Poruba
country: Czechia
facility: Pfizer Investigational Site
city: Plzen
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 2
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Praha 6
country: Czechia
facility: Pfizer Investigational Site
city: Usti nad Labem
country: Czechia
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: