Clinical trial NCT00858208: Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
Official title: Long-Term Non-Interventional Study To Investigate The Efficacy And Safety Of MACUGEN In Patients With Neovascular Age-Related Macular Degeneration Under Conditions Of Routine Clinical Practice.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: efficacy and safety of Macugen in routine clinical practice
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Age-related Macula degeneration

Brief summary: Efficacy and safety of MACUGEN in patients suffering from neovascular age-related macular degeneration in routine clinical practice at least as good as demonstrated in randomized multicenter clinical trials.

Detailed description: Eligible patients in routine clinical practice

Eligibility criteria: Inclusion Criteria:

adults with neovascular age-related macula degeneration

Exclusion Criteria:

according to SmPC

Primary outcomes:
measure: Change From Baseline Visual Acuity (VA) at the Final Visit
timeFrame: Baseline, Week 102 or Early Termination (ET)
Secondary outcomes:
measure: Change From Baseline VA at Each Visit
timeFrame: Baseline, every 6 weeks up to Week 102
measure: Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
timeFrame: Baseline, Week 102 or ET
measure: Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
timeFrame: Baseline, Month 6, 12, 18, and 24
measure: Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
timeFrame: Baseline, Week 102 or ET
measure: Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
timeFrame: Baseline, Week 102 or ET
Other outcomes:
measure: Change From Baseline VA at Final Visit by Age Group
timeFrame: Baseline, Week 102 or ET
measure: Change From Baseline VA at the Final Visit by Age-related Macular Degeneration (AMD) Stage
timeFrame: Baseline, Week 102 or ET
measure: Change From Baseline VA at the Final Visit by Previous Treatment of AMD
timeFrame: Baseline, Week 102 or ET
measure: Number of Participants for Whom Fluorescein Angiography Was Used to Monitor the Course of AMD Treatment
timeFrame: Every 6 weeks up to Week 102
measure: Number of Participants for Whom Optical Coherence Tomography Was Used to Monitor the Course of AMD Treatment
timeFrame: Every 6 weeks up to Week 102
measure: Number of Participants for Whom Indocyanine Green Angiography Was Used to Monitor the Course of AMD Treatment
timeFrame: Every 6 weeks up to Week 102
measure: Number of Participants Who Discontinued Treatment Prematurely or Changed Treatment During the Course of the Study
timeFrame: Baseline through Week 102
measure: Change From Baseline to Final Visit in Intraocular Pressure (IOP) (Before and After Injection)
timeFrame: Baseline and Week 102 or ET
Locations:
city: Patras
country: Greece
facility: Pfizer Investigational Site
state: Pellopoese
city: Alexandroupoli
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Larisa
country: Greece
facility: Pfizer Investigational Site
city: Patra
country: Greece
facility: Pfizer Investigational Site
city: Thessaloniki
country: Greece
facility: Pfizer Investigational Site
city: Xanthi
country: Greece
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: