Analyzing the clinical care and therapeutic practice of patients with neovascular age-related macular degeneration and diabetic macular edema with special consideration of the effectiveness of faricimab in treatment-naïve patients in Germany

Analyzing the clinical care and therapeutic practice of patients with neovascular age-related macular degeneration and diabetic macular edema with special consideration of the effectiveness of faricimab in treatment-naïve patients in Germany - ZEUS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00035007

Enrollment

150

Registered

2024-09-25

Start date

2024-10-09

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 (nAMD) or diabetic macular edema (DME)

Interventions

Group 1: Objective: The aim of the data analysis is to obtain information on the efficacy of faricimab in treatment-naïve patients in clinical practice (i.e. on visual acuity and dryness of affected e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Diagnosis of nAMD or DME • Naïve in intravitreal injection therapy before faricimab-therapy • At least one injection of faricimab • Availability of CRT, SRF, IRF, status of PED (only patients with nAMD), and visual acuity data in the patient file at the time of data collection • the analysis is in the period from Vabysmo approval (in label) 10.2022 to 01.10.24

Exclusion criteria

Exclusion criteria: • Participation in any other study or research project conducted by Roche • Any kind of opacity in the eye that has an influence on the visual acuity of the affected eye(s) • Any known type of intraocular surgery of the affected eye(s) in the period of data collection

Design outcomes

Primary

Measure	Time frame
To evaluate the proportion of intravitreal injection-naïve patients treated in first line with faricimab in the clinical practice of nAMD and DME from all patients treated with faricimab therapy	—

Secondary

Measure	Time frame
• To evaluate the patient and baseline characteristics of the affected eyes in intravitreal injection-naïve patients (nAMD and DME) treated in first line with faricimab • To evaluate the fluid in the macula (reduction of central foveal retinal thickness [CRT], absence of subretinal fluid [SRF] and/or intraretinal fluid [IRF]) in affected eyes after faricimab upload in intravitreal injection-naïve patients (nAMD and DME) • To evaluate the faricimab injection patterns after treatment upload in intravitreal injection-naïve patients (nAMD and DME) • To evaluate the status of pigment epithelial detachment (PED) in affected eyes after faricimab upload in intravitreal injection-naïve patients with nAMD • To evaluate the changes in visual acuity in affected eyes after faricimab treatment in intravitreal injection-naïve patients (nAMD and DME) • To evaluate the reason of faricimab therapy in intravitreal injection-naïve patientsm (nAMD and DME) in the clinical practice • To evaluate which treatment regimen, treatment upload schemata, and imaging techniques for diagnosis (including timing) are used in the clinical practice of nAMD and DME in general	—

Measure

Time frame

• To evaluate the patient and baseline characteristics of the affected eyes in intravitreal injection-naïve patients (nAMD and DME) treated in first line with faricimab • To evaluate the fluid in the macula (reduction of central foveal retinal thickness [CRT], absence of subretinal fluid [SRF] and/or intraretinal fluid [IRF]) in affected eyes after faricimab upload in intravitreal injection-naïve patients (nAMD and DME) • To evaluate the faricimab injection patterns after treatment upload in intravitreal injection-naïve patients (nAMD and DME) • To evaluate the status of pigment epithelial detachment (PED) in affected eyes after faricimab upload in intravitreal injection-naïve patients with nAMD • To evaluate the changes in visual acuity in affected eyes after faricimab treatment in intravitreal injection-naïve patients (nAMD and DME) • To evaluate the reason of faricimab therapy in intravitreal injection-naïve patientsm (nAMD and DME) in the clinical practice • To evaluate which treatment regimen, treatment upload schemata, and imaging techniques for diagnosis (including timing) are used in the clinical practice of nAMD and DME in general

—

Countries

Germany

Contacts

Public ContactSvetlana Hlopotova

Roche Pharma AG

svetlana.hlopotova@roche.com+49 7624 14-2484

Outcome results

None listed

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