The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,049
All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
Number of Participants With Systemic Drug-related Adverse Events
Monitoring and recording all adverse events, including serious adverse events.
Time frame: Baseline to Month 12
Number of Eyes With Ocular Drug-related Adverse Events
Monitoring and recording all adverse events, including serious adverse events.
Time frame: Baseline to Month 12
Overall Number of Ranibizumab Injections
Time frame: Baseline to month 12
Time Interval Between Injections in Bilateral Disease
Mean number of days between two consecutive injections per eye
Time frame: Baseline to month 12
Mean Number of Injections Per Patient
Number of injections per patient
Time frame: Baseline to month 12
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Novartis Investigative Site
Alessandria, AL, Italy
Novartis Investigative Site
Casale Monferrato, AL, Italy
Novartis Investigative Site
Ancona, AN, Italy
Novartis Investigative Site
Acquaviva delle Fonti, BA, Italy
Novartis Investigative Site
Putignano, BA, Italy
Novartis Investigative Site
Terlizzi, BA, Italy
Novartis Investigative Site
Bergamo, BG, Italy
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Belluno, BL, Italy
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Bologna, BO, Italy
Novartis Investigative Site
Brescia, BS, Italy
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