No intervention
OtherOutpatients with age-related macular degeneration (AMD)
Other names: observation only
NCT Number: NCT00787319
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Pfizer Investigational Site, Brno, Czechia
no sampling
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Outpatients with age-related macular degeneration (AMD)
Other names: observation only
Time frame: Baseline, Final Visit (Week 104 or early termination [ET])
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, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
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: Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
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 104 or End of study (EOS)
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.
Time frame: Baseline, Week 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102
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.
Time frame: Baseline up to Week 104 (EOS)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Time frame: Baseline up to Week 104 (EOS)
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.
Time frame: Baseline up to Week 104 (EOS)
Time frame: Baseline up to Week 104 (EOS)
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.
Pfizer
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02941263
Age-Related Macular Degeneration, Eye Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT01352975
Age-Related Macular Degeneration, Eye Diseases
Bethesda, Maryland, United States
View Trial DetailsNCT06190093
Age-Related Macular Degeneration, Eye Diseases
Arcadia, California, United States
View Trial DetailsNCT06164587
Age-Related Macular Degeneration, Eye Diseases
Loma Linda, California, United States
View Trial Details