Observational Study to Assess Intravitreal Aflibercept Injections Used in a Treat and Extend Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients

Study Overview
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Brief Summary
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The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.

Detailed Description
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Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.

Official Title
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An Observational Study to Assess the Use of Intravitreal Aflibercept Injections in a Routine Treat and Extend Regimen in Treatment-naïve Patients Diagnosed With Wet Age-related Macular Degeneration

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: Diagnosis of wet age-related macular degeneration. No prior therapy for wet age-related macular degeneration. Patients for whom the decision to initiate treatment with IVT-AFL in a T&E regimen was made as per routine clinical practice. Patient age >55 years of age Exclusion Criteria: Participation in an investigational program with therapeutical interventions outside of clinical routine practice. 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 commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye

Ages Eligible for Study
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Minimum Age: 55 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 |
| --- | --- |
| Aflibercept<br>Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme | Drug: Aflibercept (Eylea, BAY86-5321)<br>* Intravitreal aflibercept injections used in a routine treat and extend regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters) | mean change in ETDRS letters | Baseline and at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters) | mean change in ETDRS letters | Baseline and at 24 months | 
| Mean change in best-corrected visual acuity in relation to the number of injections administered | Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes | Baseline and at 12 months; Baseline and at 24 months | 
| Mean interval between injections | mean interval displayed in weeks or days | At 12 and 24 months | 
| Reasons for the interval length | morphology and / or BCVA /other | At 12 and 24 months | 
| Frequency of disease reactivation | Disease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator's discretion as: none / new or increasing / decreasing / stable | Baseline and at 12 months; Baseline and at 24 months | 
| Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline | Proportion evaluated as percentage (%) of eyes | Baseline and at 12 months; Baseline and at 24 months | 
| Mean changes from baseline in central retinal thickness (CRT) | micro meter (µm) | Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months | 
| Changes from baseline in retinal fluid | intraretinal or subretinal fluid or pigment epithelial detachment (PED) | Baseline and at 12 months; Baseline and at 24 months | 
| Reasons for termination of therapy (including subsequent therapy at time of discontinuation) | Categorized into typical reasons for discontinuation such as e.g. death, lost to Follow-up, withdrawal of informed consent, change of treatment regimen, discontinuation of IVT-AFL treatment, interfering surgery or treatment, adverse event, other | At 12 and 24 months | 
| Severity of disease reactivation | Severity of disease reactivation assessed at the investigator's discretion as: no new disease activity / mild / severe | Baseline and at 12 months; Baseline and at 24 months |