Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)

Study Overview
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Brief Summary
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There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice. The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.

Official Title
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Observational, Retrospective Study to Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)

Conditions
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Macular Degeneration

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patient aged 50 years or more at aflibercept treatment initiation. Treatment-naïve patients with nAMD Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016 Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC. Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent. Exclusion Criteria: Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye. Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks. Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation Patients with advanced cataract or advanced glaucoma Patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation. Patients who do not meet the local Guideline criteria for aflibercept treatment. Contraindications listed in the SmPC must be taken into account.

Ages Eligible for Study
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Minimum Age: 50 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 |
| --- | --- |
| Treatment-naïve nAMD patients<br>Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice. | Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)<br>* IVT(Intravitreal) aflibercept treatment in routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in VA | The mean change in VA from baseline (i.e. just prior to the start of treatment) to 12 months in treatment-naïve patients with nAMD in routine clinical practice in Spain. | From baseline to month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in VA |  | From baseline to month 6 | 
| Proportion of patients gaining 15 or more letters |  | At month 6 and 12 | 
| Mean change in CRT in µm (measured by OCT) | OCT:Optical Coherence Tomography | From baseline to months 6 and 12 | 
| Presence/absence of SRF (subretinal fluid) by OCT (yes/no) |  | At months 6 and 12 | 
| Presence/absence of IRF (intraretinal fluid) by OCT (yes/no) |  | At months 6 and 12 | 
| Presence/absence of PED (pigment epithelium detachment) (measured by OCT) | Absence of PED: when the maximum distance between the outer border of the RPE and the inner border of the Bruch membrane is <30 μm | At months 6 and 12 | 
| Presence/absence of PED Height | Subfoveal and 500µm nasal and temporal; PED height defined as the distance between the outer border of the retinal pigment epithelium (RPE) and the inner border of the Bruch membrane | At months 6 and 12 | 
| Presence/absence of PED type | Serous-vascularized or fibrovascular | At months 6 and 12 | 
| Correlation of the mean gain in VA with the total number of injections administered |  | 12 months | 
| Mean number of IVT aflibercept injections per study eye |  | The first 12 months | 
| Mean number of monitoring visits per study eye | Visits only for diagnostic/follow-up purposes, but without injections | The first 12 months | 
| Mean number of combined visits per study eye | Visits for monitoring and injection | The first 12 months | 
| Mean number of OCT assessments per study eye |  | The first 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nAMD: neovascular Age-related Macular Degeneration