The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.
The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO). Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.
Study Type
OBSERVATIONAL
Enrollment
73
Intravitreal injection of aflibercept as scheduled by treating physician
Many locations
Multiple Locations, Mexico
Number of ocular adverse events
Time frame: Up to 12 months
Number of serious ocular adverse events
Time frame: Up to 12 months
Seriousness reason for ocular adverse events
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Time frame: Up to 12 months
Severity of ocular adverse events
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Time frame: Up to 12 months
Number of treatment-related ocular adverse events
Time frame: Up to 12 months
Number of injection-related ocular adverse events
Time frame: Up to 12 months
Action taken with drug after ocular adverse event
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Time frame: Up to 12 months
Clinical outcome of ocular adverse event
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Time frame: Up to 12 months
Duration of ocular adverse events
Time frame: Up to 12 months
Duration of patient follow-up after ocular adverse event (in months)
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Time frame: Up to 12 months
Number of non-ocular adverse events
Time frame: Up to 12 months
Number of serious non-ocular adverse events
Time frame: Up to 12 months
Seriousness reason for non-ocular adverse events
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Time frame: Up to 12 months
Severity of non-ocular adverse events
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Time frame: Up to 12 months
Number of treatment-related non-ocular adverse events
Time frame: Up to 12 months
Number of injection-related non-ocular adverse events
Time frame: Up to 12 months
Action taken with drug after non-ocular adverse event
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Time frame: Up to 12 months
Clinical outcome of non-ocular adverse event
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Time frame: Up to 12 months
Duration of non-ocular adverse events
Time frame: Up to 12 months
Duration of patient follow-up after non-ocular adverse event (in months)
Time frame: Up to 12 months
Total number of injections with intravitreal aflibercept per study eye
Time frame: Up to 12 months
Time between injections in the study eye (in days)
Time frame: Up to 12 months
Time between injections in the study eye and fellow eye (in days)
Time frame: Up to 12 months
Number of patients receiving bilateral treatment
Time frame: Up to 18 months