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Sponsor Decision
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The purpose of this research study is to observe the patient's clinical care and how EYLEA® HD is used as a treatment in real-world settings. Patients are asked to join the study because they have either neovascular age-related macular degeneration (nAMD/wet age-related macular degeneration [AMD]) or diabetic macular edema (DME). Patients cannot have used EYLEA® HD in the past and the doctor must be planning to treat nAMD or DME with a new prescription of EYLEA® HD (aflibercept 8 mg).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naïve nAMD | Treatment-naive patients with nAMD |
| |
| Pretreated nAMD | Patients with nAMD who have been previously treated with anti-VEGF and/or laser |
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| Naïve DME | Treatment-naive patients with DME |
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| Pretreated DME | Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aflibercept 8 mg | Drug | No intervention will be provided to study patients. Any treatment decision, including the decision for aflibercept 8 mg treatment, is at the discretion of the attending physician, made in accordance with his/her experience and following approved clinical guidelines. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study | Previously Treated Patient Cohorts: Reported among the subsets of patients (nAMD and DME) treated at dosing intervals of ≤ 8 weeks for ≥ 6 months prior to enrollment | Up to 12 Months |
| Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters) | Treatment-Naïve Patient Cohorts | Baseline up to 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in VA (ETDRS letters) | Baseline up to 24 Months | |
| Categorical gains of ≥5 ETDRS letters | Up to 24 Months | |
| Categorical gains of ≥10 ETDRS letters |
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Key Inclusion Criteria for Patients with nAMD:
Key Inclusion Criteria for Patients with DME:
Key Exclusion Criteria for Patients with nAMD
Key Exclusion Criteria for Patients with DME:
NOTE: Other Protocol-Defined Inclusion / Exclusion Criteria Apply
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Previously treated and treatment-naïve patients that have a diagnosis of nAMD or DME will be enrolled into this study. Patients who are treated with aflibercept 8 mg for other indications besides nAMD or DME will not be included.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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|
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| Up to 24 Months |
| Categorical gains of ≥15 ETDRS letters | Up to 24 Months |
| Categorical losses of ≥5 ETDRS letters | Up to 24 Months |
| Categorical losses of ≥10 ETDRS letters | Up to 24 Months |
| Categorical losses of ≥15 ETDRS letters | Up to 24 Months |
| Proportion of patients achieving 20/40 Snellen equivalent or better | Up to 24 Months |
| Change in Central subfield thickness (CST) | Baseline up to 24 Months |
| Description of demographics | Standard and clinical characteristics such as age, sex and race/ethnicity | At Baseline |
| Descriptions of study eye characteristics | Study eye characteristics include ocular history, medical history (duration of nAMD or DME), prior and concomitant medication history, prior and concomitant ocular surgeries | At Baseline |
| Treatment interval | Up to 24 Months |
| Missed and unscheduled visits | Up to 24 Months |
| Frequency of ocular adverse events (AEs) | Up to 24 Months |
| Frequency of non-ocular adverse events (AEs) | Up to 24 Months |
| ID | Term |
|---|---|
| D014786 | Vision Disorders |
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012164 | Retinal Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C533178 | aflibercept |
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