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

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT06398080
Status
Withdrawn

Conditions

  • Diabetic Macular Edema (DME)
  • Neovascular Age-related Macular Degeneration (nAMD)
  • Visual Impairment
  • Wet Age-related Macular Degeneration (AMD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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).

Key Dates

Start date
Dec 12, 2024
Status verified
Nov 2024
Primary completion
Jan 3, 2028
Completion
Jan 3, 2029

Study Design

Enrollment
0 participants (actual)

Arms

  • Arm: Naïve nAMD
    Treatment-naive patients with nAMD
  • Arm: Pretreated nAMD
    Patients with nAMD who have been previously treated with anti-VEGF and/or laser
  • Arm: Naïve DME
    Treatment-naive patients with DME
  • Arm: Pretreated DME
    Patients with DME who have been previously treated with anti-VEGF, laser treatment, and/or intravitreal steroids

Primary Outcome Measure

Mean prior treatment interval during the one-year period before study enrollment compared to the last assigned treatment interval during the study [ Time Frame: Up to 12 Months ]

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