check_circleStudy Completed
Retinal disease
Bayer Identifier:
19212
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study to gather information on the safety and use of aflibercept injections into the eye for the treatment of eye disorders in Mexican routine clinical practice
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
73Trial Dates
February 2021 - February 2023Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Recruiting | Many locations | Many locations, Mexico |
Primary Outcome
- Number of ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Number of serious ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Seriousness reason for ocular adverse eventsSeriousness 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.date_rangeTime Frame:Up to 12 months
- Severity of ocular adverse eventsThe severity of adverse events is classified as mild, moderate or severe by treating physician.date_rangeTime Frame:Up to 12 months
- Number of treatment-related ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Number of injection-related ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Action taken with drug after ocular adverse eventOptions: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changeddate_rangeTime Frame:Up to 12 months
- Clinical outcome of ocular adverse eventOptions: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknowndate_rangeTime Frame:Up to 12 months
- Duration of ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Duration of patient follow-up after ocular adverse event (in months)date_rangeTime Frame:Up to 12 months
- Number of non-ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Number of serious non-ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Seriousness reason for non-ocular adverse eventsSeriousness 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.date_rangeTime Frame:Up to 12 months
- Severity of non-ocular adverse eventsThe severity of adverse events is classified as mild, moderate or severe by treating physician.date_rangeTime Frame:Up to 12 months
- Number of treatment-related non-ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Number of injection-related non-ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Action taken with drug after non-ocular adverse eventOptions: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changeddate_rangeTime Frame:Up to 12 months
- Clinical outcome of non-ocular adverse eventOptions: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknowndate_rangeTime Frame:Up to 12 months
- Duration of non-ocular adverse eventsdate_rangeTime Frame:Up to 12 months
- Duration of patient follow-up after non-ocular adverse event (in months)date_rangeTime Frame:Up to 12 months
Secondary Outcome
- Total number of injections with intravitreal aflibercept per study eyedate_rangeTime Frame:Up to 12 months
- Time between injections in the study eye (in days)date_rangeTime Frame:Up to 12 months
- Time between injections in the study eye and fellow eye (in days)date_rangeTime Frame:Up to 12 months
- Number of patients receiving bilateral treatmentdate_rangeTime Frame:Up to 18 months
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A