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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00858208 |
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Date of registration:
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26/02/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy And Safety Of Macugen In Patients With Neovascular AMD In Routine Clinical Practice.
MACULA |
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Scientific title:
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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. |
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Date of first enrolment:
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March 2008 |
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Target sample size:
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86 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00858208 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
adults with neovascular age-related macula degeneration
Exclusion Criteria:
according to SmPC
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Neovascular Age-related Macular Degeneration
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Intervention(s)
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Drug: pegaptanib sodium
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Primary Outcome(s)
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Change From Baseline Visual Acuity (VA) at the Final Visit
[Time Frame: Baseline, Week 102 or Early Termination (ET)]
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Secondary Outcome(s)
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Change From Baseline NEI-VFQ-25 Sub-scale Scores at Final Visit
[Time Frame: Baseline, Week 102 or ET]
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Each Visit
[Time Frame: Baseline, Month 6, 12, 18, and 24]
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Change From Baseline NEI-VFQ-25 Overall Composite Score at Final Visit
[Time Frame: Baseline, Week 102 or ET]
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Change From Baseline VA at Each Visit
[Time Frame: Baseline, every 6 weeks up to Week 102]
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Change From Baseline VA at the Final Visit for Participants With Vascular Retinal Pigment Epithelial Detachment (RPED)
[Time Frame: Baseline, Week 102 or ET]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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