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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Assessment of the Safety and Drug Utilization of Intravitreal Aflibercept Injection in Mexican Routine Clinical Practice for the Treatment of Wet Age Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO), Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) and Myopic Neovascularization (mCNV). A Post-authorization Safety Study (PASS).

Conditions
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Retinal Disease

Intervention / Treatment
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* Drug: Aflibercept (BAY86-5321, Eylea)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV); Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion; Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation; If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept 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: Ocular or periocular infection Active intraocular Inflammation Known hypersensitivity to aflibercept or to any of its excipients Pregnant or lactating women. Participation in an interventional study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients_Ocular disease<br>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) | Drug: Aflibercept (BAY86-5321, Eylea)<br>* Intravitreal injection of aflibercept as scheduled by treating physician<br>* Other names: Eylea®; Eylia®; Wetlia®; VEGF Trap-Eye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mexico, Aflibercept, Intravitreal injection, Ocular disease, Wet age-related macular degeneration (wAMD), Diabetic macular edema (DME), Macular edema secondary to central retinal vein occlusion (CRVO), Macular edema secondary to branch retinal vein occlusion (BRVO), Myopic choroidal neovascularization (mCNV)