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).
Study Type
OBSERVATIONAL
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.
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
Time frame: Up to 12 Months
Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters)
Treatment-Naïve Patient Cohorts
Time frame: Baseline up to 12 Months
Change in VA (ETDRS letters)
Time frame: Baseline up to 24 Months
Categorical gains of ≥5 ETDRS letters
Time frame: Up to 24 Months
Categorical gains of ≥10 ETDRS letters
Time frame: Up to 24 Months
Categorical gains of ≥15 ETDRS letters
Time frame: Up to 24 Months
Categorical losses of ≥5 ETDRS letters
Time frame: Up to 24 Months
Categorical losses of ≥10 ETDRS letters
Time frame: Up to 24 Months
Categorical losses of ≥15 ETDRS letters
Time frame: Up to 24 Months
Proportion of patients achieving 20/40 Snellen equivalent or better
Time frame: Up to 24 Months
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Change in Central subfield thickness (CST)
Time frame: Baseline up to 24 Months
Description of demographics
Standard and clinical characteristics such as age, sex and race/ethnicity
Time frame: 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
Time frame: At Baseline
Treatment interval
Time frame: Up to 24 Months
Missed and unscheduled visits
Time frame: Up to 24 Months
Frequency of ocular adverse events (AEs)
Time frame: Up to 24 Months
Frequency of non-ocular adverse events (AEs)
Time frame: Up to 24 Months