CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,479 enrolled
Drug / intervention
Faricimab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04432831
NCT04432831Phase 3Completed
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A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Diabetic Macular Edema

Hoffmann-La Roche·interventional·Posted Jun 16, 2020·Updated Feb 9, 2026

In Brief

A Phase 3 clinical trial evaluating Faricimab and Sham Procedure for Diabetic Macular Edema. Completed, enrolled 1,479 participants across 320 sites in 30 countries.

Detailed Summary

This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab administered by intravitreal (IVT) injection at a personalized treatment interval (PTI) to participants who enrolled in and completed one of the two Phase III studies, GR40349 (NCT03622580) or GR40398 (NCT03622593), also referred to as the parent studies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesArgentina, Australia, Austria, Brazil, Bulgaria, Canada, Czechia, Denmark, France, Germany, Hong Kong, Hungary, Israel, Italy, Japan, Mexico, Peru, Poland, Portugal, Russia, Singapore, Slovakia, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedJun 16, 2020
Enrollment StartAug 5, 2020
Primary CompletionOct 11, 2023
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 6.0 years ago

Interventions

Faricimabdrug

Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.

Sham Procedureother

The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.