An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
- Conditions
- Neovascular Age-related Macular Degeneration (nAMD)Wet Age-related Macular Degeneration (AMD)Diabetic Macular Edema (DME)Visual Impairment
- Interventions
- Registration Number
- NCT06398080
- Lead Sponsor
- Regeneron Pharmaceuticals
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pretreated DME aflibercept 8 mg Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids Naïve nAMD aflibercept 8 mg Treatment-naive patients with nAMD Pretreated nAMD aflibercept 8 mg Patients with nAMD who have been previously treated with anti-VEGF and/or laser Naïve DME aflibercept 8 mg Treatment-naive patients with DME
- Primary Outcome Measures
Name Time Method Change in visual acuity (VA) (Early Treatment Diabetic Retinopathy study [ETDRS]) letters) Baseline up to 12 Months Treatment-Naïve Patient Cohorts
Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study Up to 12 Months 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
- Secondary Outcome Measures
Name Time Method Change in VA (ETDRS letters) Baseline up to 24 Months Categorical losses of ≥15 ETDRS letters Up to 24 Months Treatment interval Up to 24 Months Frequency of non-ocular adverse events (AEs) Up to 24 Months Categorical gains of ≥5 ETDRS letters Up to 24 Months Categorical gains of ≥10 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 Descriptions of study eye characteristics At Baseline Study eye characteristics include ocular history, medical history (duration of nAMD or DME), prior and concomitant medication history, prior and concomitant ocular surgeries
Categorical gains 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 At Baseline Standard and clinical characteristics such as age, sex and race/ethnicity
Frequency of ocular adverse events (AEs) Up to 24 Months Missed and unscheduled visits Up to 24 Months