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).

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). - FATE

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00031548

Enrollment

136

Registered

2023-03-24

Start date

2023-03-22

Completion date

Unknown

Last updated

2025-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

age-related macular degeneration H36.0 H35.3

Interventions

Group 1: Patients with neovascular age-related makuladegeneration or diabetic macular edema with intravitreal Faricimab-injections in a treat-and-extend-regimen every 4-16 Weeks Dose: 6mg (? 0,05 ml á

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Number of injections. Reduction of the required injections of one drug by 2 injections compared to the other drug within one year.	—

Secondary

Measure	Time frame
visual acuity increase	—

Countries

Germany

Contacts

Public ContactJan Tode

Augenklinik der Medizinischen Hochschule Hannover

tode.jan@mh-hannover.de0511 532 9411

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026