MedTrace Logo

Intravitreal Faricimab in Diabetic Macular Edema With Limited Response to Aflibercept

NCT05610488 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-11-09

No results posted yet for this study

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)

Conditions

Interventions

DRUG

FARICIMAB 6 Mg in 0.05 mL INTRAVITREAL INJECTION, SOLUTION [VABYSMO]

Intravitreal injection of faricimab 6 mg at baseline (week 0), at week 4, 8, 12 (=4x loading) and each of the following treat and extend visits

Sponsors & Collaborators

  • Vista Klinik

    lead OTHER

Principal Investigators

  • Katja Hatz, MD · Vista Augenklinik Binningen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-12-31
Completion
2023-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05610488 on ClinicalTrials.gov