Clinical Trials List
Protocol NumberGR41987
NCT Number(ClinicalTrials.gov Identfier)NCT04432831
Completed
2020-12-01 - 2024-06-30
Phase III
Recruiting3
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF FARICIMAB IN PATIENTS WITH DIABETIC MACULAR EDEMA
-
Trial Applicant
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳冠任 Division of Ophthalmology
- 劉珍吟 Division of Ophthalmology
- 周宏達 無
- Yih-Shiou Hwang Division of Ophthalmology
- Wei-Chi WU Division of Ophthalmology
- 陳墩祿 Division of Ophthalmology
- 陳彥伯 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- TSO-TING LAI Division of Ophthalmology
- 謝易庭 Division of Ophthalmology
- CHUNG-MAY YANG Division of Ophthalmology
- Ta-Ching Chen Division of Ophthalmology
- 葉伯廷 Division of Ophthalmology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Diabetic Macular Edema
Objectives
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.
Test Drug
FARICIMAB (RO6867461)
Active Ingredient
FARICIMAB (RO6867461)
Dosage Form
IVT
Dosage
6 mg/ 0.05 ml
Endpoints
Primary Outcome Measures :
Incidence and Severity of Ocular Adverse Events [ Time Frame: Up to 2 years ]
Incidence and Severity of Systemic (Non-Ocular) Adverse Events [ Time Frame: Up to 2 years ]
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study [ Time Frame: From Baseline up to 2 years ]
Incidence and Severity of Ocular Adverse Events [ Time Frame: Up to 2 years ]
Incidence and Severity of Systemic (Non-Ocular) Adverse Events [ Time Frame: Up to 2 years ]
Number of Participants with Presence of Anti-Drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study [ Time Frame: From Baseline up to 2 years ]
Inclution 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
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
Exclusion Criteria:
Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days 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
Pregnant or breastfeeding, or intending to become pregnant during the study or within 28 days 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
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
1800 participants
