Assessment of Proactive Treatments in Patients With Wet Age-related Macular Degeneration (wAMD) Which Have Never Undergone Treatment of This Particular Disease

Study Overview
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Brief Summary
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In this observational study researchers want to learn more about changes in visual acuity (clarity of vision) with proactive flexible treatments over time in patients suffering from wet age-related macular degeneration (wAMD) after decision to treat with Aflibercept (Eylea) was made. Wet AMD is an eye disease that progressively destroys the macula, the central portion of the retina, impairing central vision.

Official Title
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Evaluation of an eXtended and proacTive Dosing regimEn in Treatment-Naïve Patients With Wet Age-related Macular Degeneration (wAMD)

Conditions
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Wet Age-related Macular Degeneration

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of wAMD. Patients for whom the decision to initiate treatment with IVT aflibercept in a proactive regimen was made as routine clinical practice. Treatment-naïve in the study eye (no prior therapy for wAMD). Patient age ≥50 years of age. Written informed patient consent before the start of data collection (according to the requirements of the local authorities and laws). Exclusion Criteria: Participation in an investigational program with interventions outside of routine clinical practice. Patients with contraindications to IVT aflibercept listed in the local marketing authorization. Planned treatment regimen outside of the local marketing authorization. Patients with eye diseases, e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye. Concomitant ocular or systemic administration of drugs up to 3 months before IVT aflibercept treatment that could interfere with or potentiate the mechanism of action of IVT aflibercept, including other anti-VEGF agents in the fellow eye. Any other retinal disease which may interfere with the treatment of wAMD.

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 |
| --- | --- |
| wAMD patients<br>Patients with a diagnosis of wAMD and naïve to any treatment in the study eye will be enrolled after the decision by treating physician for IVT aflibercept therapy according to the local label. | Drug: Aflibercept (Eylea, BAY86-5321)<br>* As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in BCVA (best corrected visual acuity) | In treatment-naïve wAMD patients treated with IVT aflibercept in a flexible proactive treatment pattern (fixed dosing or T&E (Treat and Extend Regimen)) by label regimen. | Baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in BCVA |  | Baseline to 24 and 36 months | 
| The change in BCVA by intended treatment regimen |  | Baseline to 12, 24 and 36 months | 
| The proportion of patients (eyes) gaining or losing a visual acuity compared to baseline | With letter score of ≥ 0 letters, ≥5 letters, ≥ 10 letters, ≥ 15 letters. | Baseline at 12, 24 and 36 months | 
| The proportion of patients (eyes) achieving a Snellen equivalent of 20/40 or better |  | At 12, 24 and 36 months | 
| The changes in central retinal thickness (CRT) |  | Baseline to 12, 24 and 36 months | 
| The number of injections |  | Baseline to 12, 24 and 36 months | 
| The distribution of the intervals between injections |  | Up to 36 months |