observational comparative study: Intravitreal treatment of neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME) with a bispecific antibody Vabysmo® (faricimab) vs. a classical anti-VEGF inhibitor Eylea® (aflibercept) in a treat-and-extend-regimen (FATE).
Phase 4
Recruiting
- Conditions
- Diabetic retinopathyH35.30H36.0
- Registration Number
- DRKS00031548
- Lead Sponsor
- Augenklinik der Medizinischen Hochschule Hannover
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 136
Inclusion Criteria
Consenting patients with macular edema, with underlying cause: neovascular age-related macular degeneration, diabetes mellitus-related maculopathy.
Minimum age 18 years, gender male/female/diverse.
Exclusion Criteria
Macular edema caused or influenced by an underlying cause other than neovascular age-related macular degeneration or diabetes mellitus-related maculopathy.
lack of capacity to consent.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of injections. Reduction of the required injections of one drug by 2 injections compared to the other drug within one year.
- Secondary Outcome Measures
Name Time Method visual acuity increase