Phase 3
N=1,474
A Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Participants With Diabetic Macular Edema
Diabetic Macular Edema
Bottom Line
View on ClinicalTrials.gov: NCT04432831 ↗Enrolled (actual)
1,474
Serious AEs
28.4%
Results posted
Oct 2024
Primary outcome: Primary: Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale — 219; 188; 197; 119 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Faricimab (Drug); Sham Procedure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence and Severity of Ocular Adverse Events in the Study Eye, With Severity Determined According to Adverse Event Severity Grading Scale |
219; 188; 197; 119; 109; 109 | — |
| PRIMARY Incidence of Ocular Adverse Events in the Fellow Eye |
186; 185; 179; 16; 17; 15 | — |
| PRIMARY Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale |
317; 295; 297; 91; 94; 97 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04432831). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.