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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients_Ocular disease | Adult patients treated for wet age-related macular degeneration (wAMD), or diabetic macular edema (DME), or macular edema secondary to central retinal vein occlusion (CRVO), or macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV) in routine clinical practice in Mexico (overall cohort) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aflibercept (BAY86-5321, Eylea) | Drug | Intravitreal injection of aflibercept as scheduled by treating physician |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of ocular adverse events | Up to 12 months | |
| Number of serious ocular adverse events | 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. | Up to 12 months |
| Severity of ocular adverse events | The severity of adverse events is classified as mild, moderate or severe by treating physician. | Up to 12 months |
| Number of treatment-related ocular adverse events | Up to 12 months | |
| Number of injection-related ocular adverse events | Up to 12 months | |
| Action taken with drug after ocular adverse event | Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed | Up to 12 months |
| Clinical outcome of ocular adverse event | Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown | Up to 12 months |
| Duration of ocular adverse events |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of injections with intravitreal aflibercept per study eye | Up to 12 months | |
| Time between injections in the study eye (in days) | Up to 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
Current treatment with other intravitreal therapies
Contra-indications according to Eylea's / Wetlia's local marketing authorization:
Participation in an interventional study
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Adults with macular disease in Mexican routine practice
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | Mexico |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.
As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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| Up to 12 months |
| Duration of patient follow-up after ocular adverse event (in months) | Up to 12 months |
| Number of non-ocular adverse events | Up to 12 months |
| Number of serious non-ocular adverse events | 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. | 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. | Up to 12 months |
| Number of treatment-related non-ocular adverse events | Up to 12 months |
| Number of injection-related non-ocular adverse events | Up to 12 months |
| Action taken with drug after non-ocular adverse event | Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed | Up to 12 months |
| Clinical outcome of non-ocular adverse event | Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown | Up to 12 months |
| Duration of non-ocular adverse events | Up to 12 months |
| Duration of patient follow-up after non-ocular adverse event (in months) | Up to 12 months |
| Time between injections in the study eye and fellow eye (in days) |
| Up to 12 months |
| Number of patients receiving bilateral treatment | Up to 18 months |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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