drugset / Trial / NCT05610488

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

NCT05610488

Phase 4 Unknown 30 enrolled Vista Klinik
NaSingle-groupOpen-labelTreatment

Summary

Title: Intravitreal faricimab in diabetic macular edema with limited response to aflibercept Purpose: The purpose of this investigator initiated study is to identify the effects of intravitreal faricimab on recurrence-free treatment intervals and morphological features in diabetic macular edema (DME) in which the Optical coherence tomography (OCT) guided treatment interval failed to be extended to 6 weeks intervals in a treat and extend regimen using aflibercept. Objectives: The primary objective is to evaluate the proportion of patients with an increased maximum treatment interval with intravitreal faricimab (compared to previous 4-week interval under aflibercept) in an OCT guided treat and extend regimen at month 6 and 12. (for further outcome measures see section Objectives)

Timeline

Start
2022-11
Primary completion
2023-12
Completion
2023-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Faricimab Monoclonal antibody 6 mg Intravitreal