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Study identifier: NCT04432831 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: CompletedRhone-X

A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema

Condition: Diabetic Macular Edema  ·  Sponsor: Hoffmann-La Roche

PhasePhase 3
Planned participants1479
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where320 locations · 30 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

Inclusion Criteria: * Previous enrollment in and completion of Study GR40349 (NCT03622580) or GR40398 (NCT03622593), without study or study drug discontinuation * Ability to comply with the study protocol, in the investigator's judgment * For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 3 months after the final dose of study treatment Exclusion Criteria: * Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final intravitreal injection of faricimab * Presence of other ocular diseases that give reasonable suspicion of a disease or condition that contraindicates the use of faricimab, that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications * Presence of other diseases, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of faricimab and that might affect interpretation of the results of the study or that renders the patient at high risk of treatment complications * History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the faricimab injections, study treatment procedure, dilating drops, or any of the anesthetic and antimicrobial preparations used by a patient during the study * Requirement for continuous use of any medications or treatments indicated as prohibited therapy

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (320)

Barnet Dulaney Perkins Eye CenterMesa, Arizona, United States
Retinal Research Institute, LLCPhoenix, Arizona, United States
Arizona Retina and Vitreous ConsultantsPhoenix, Arizona, United States
Retina Associates Southwest PCTucson, Arizona, United States
California Retina Consultants.Bakersfield, California, United States
Retina-Vitreous Associates Medical GroupBeverly Hills, California, United States
Retinal Diagnostic CenterCampbell, California, United States
The Retina PartnersEncino, California, United States
Eye Medical CenterFresno, California, United States
Retina Consultants of Orange CountyFullerton, California, United States
Southern California Permanente Medical GroupLos Angeles, California, United States
Northern California Retina Vitreous AssociatesMountain View, California, United States

+ 308 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

MesaPhoenixTucsonBakersfield

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