PEP

Actively Recruiting // Age-related Macular Degeneration // Clinical Trials // Diabetic Macular Edema // Mihai Mititelu // Neovascular AMD // Aug 24 2021

Patient Experience and Preference (PEP) Study in nAMD and DME

  • Sponsor: Hoffmann-La Roche Ltd
  • Principal Investigator: Mihai Mititelu, MD, MPH
  • Study Coordinator: Kris Dietzman

Study objective:

To identify reasons for not being able/willing to follow management plan for intravitreal injections among patients/caregivers with neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME).

Study design:

The study involves a 30–60-minute survey via paper, online or telephone interview.

Inclusion criteria:

Patients

  • Aged 18 years or older with a physician-confirmed diagnosis of either nAMD or DME
  • Have had anti-VEGF IVT injection treatment initiated at least 6 months before March 2020, to ensure patients have treatment experience prior to the COVID-19 outbreak a. Most recent anti-VEGF IVT injection should have occurred within 6 months of the screening date
  • Have a minimum of 18-month medical records data available to the site for extraction

Caregivers

  • Aged 18 years or older
  • Be the primary caregiver of an adult patient with a confirmed diagnosis of either DME or nAMD

Exclusion criteria:

  • Currently enrolled in any clinical trial for any conditions
  • Patients who are receiving or have ever received anti-VEGF therapy in a clinical trial for retinal diseases
  • For patients with nAMD:
    • Any current or history of DME, retinal vein occlusion, or myopic choroidal neovascularization
    • Any current or history of diabetic retinopathy treated with anti-VEGF IVT
  • For patients with DME, any current or history of nAMD, retinal vein occlusion, or myopic choroidal neovascularization

Contact Kris Dietzman with questions, 608-263-9035