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.
Eligible patients in routine clinical practice
Study Type
OBSERVATIONAL
Enrollment
86
pegaptanib sodium intravitreal injection every 6 weeks for 2 years
Pfizer Investigational Site
Pátrai, Pellopoese, Greece
Pfizer Investigational Site
Alexandroupoli, Greece
Pfizer Investigational Site
Athens, Greece
Pfizer Investigational Site
Athens, Greece
Change From Baseline Visual Acuity (VA) at the Final Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time frame: Baseline, Week 102 or Early Termination (ET)
Change From Baseline VA at Each Visit
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA.
Time frame: Baseline, every 6 weeks up to Week 102
Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
VA measured using Early Treatment Diabetic Retinopathy Study (ETDRS), Snellen chart, or other methods verifying if the participant was able to count fingers, perceive hand motion, or light. VA expressed as the logarithm of the minimum angle of resolution (logMAR), and could range from 0 (representing 20/20 vision) to 1. Change: VA Score at Visit X minus VA Score at Baseline, where a negative change in the logMAR scale represents an improvement in VA. On the case report form, participants with RPED=those with the "Pigment Epithelial Detachment (PED) present" box ticked at Baseline Visit.
Time frame: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
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Pfizer Investigational Site
Larissa, Greece
Pfizer Investigational Site
Pátrai, Greece
Pfizer Investigational Site
Thessaloniki, Greece
Pfizer Investigational Site
Xánthi, Greece
Time frame: Baseline, Month 6, 12, 18, and 24
Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general health category. Mean score calculated for each category. Overall composite score=mean of 11 vision-targeted sub categories. Range of composite score=0 to 100 where higher scores represent better functioning. Change: Composite score at Visit X minus composite Score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Week 102 or ET
Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
Participant-reported 25 item questionnaire. Responses to each question converted to 0-100 score. Questions grouped into 11 vision-targeted categories and 1 general heath category. Sub-scale score=mean score in a category. Range of sub-scale scores=0 to 100 where higher scores represent better functioning. Change: Sub-scale scores score at Visit X minus sub-scale score at Baseline, where higher scores represent better functioning.
Time frame: Baseline, Week 102 or ET