333
Participants
Start Date
May 29, 2024
Primary Completion Date
December 30, 2025
Study Completion Date
March 22, 2026
8 mg aflibercept (BAY 86-5321) (High Dose)
High-dose (HD) aflibercept is the sponsor's study intervention under investigation. Dose formulation: solution in vial. Unit dose strength: 114.3 mg/mL, Dosage Level: 8 mg (70 µL), Route of Administration: Intravitreal (IVT) injection every 16 weeks following 3 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 3 mL glass vials. Each vial will be labeled as required per country requirement.
2 mg aflibercept (EYLEA, BAY 86-5321)
"Aflibercept 2 mg is the sponsor's active comparator. Dose formulation: solution in vial. Unit dose strength: 40 mg/mL, Dosage Level: 2 mg (50 µL), Route of Administration: Intravitreal (IVT) injection every 8 weeks following 5 initial monthly doses. Packaging/ Labeling: Study Intervention will be provided in sterile 2 mL glass vials. Each vial will be labeled as required per country requirement. Aflibercept 2 mg for the non-study fellow eye treatment is considered an auxiliary medicinal product (AxMP) in this study. Fellow eye treatment will be allowed with 2 mg aflibercept, at the investigator's discretion for indications approved by governing authorities. The treated fellow eye will not be considered an additional study eye."
Sham
"To preserve masking, sham injections will be performed for all participants at treatment visits in which participants do not receive an active injection through Week 56. Sham kits will be assigned for visits requiring sham injections. The sham kits are empty but should be handled in the same way as the active study intervention kits.~Sham injections will be given on visits when an active injection is not planned. During the study treatment period all participants will receive either an active injection (8 mg or 2 mg aflibercept) or a sham injection (for masking purposes) following their assigned treatment group and eligibility for Dose regimen modification (DRM)."
Tseung Kwan O Hospital, Tseung Kwan O
Beijing Aier Intech Eye Hospital, Beijing
Beijing Friendship Hospital, Capital Medical University, Beijing
Capital Medical University (CMU) - Beijing Tongren Hospital, Beijing
Beijing Hospital, Beijing
Shenyang He Eye Specialist Hospital, Shenyang
The Fourth People's Hospital of Shenyang, Shenyang
The Second Hospital of Jilin University, Changchun
The First Hospital of Jilin University, Changchun
The First Affiliated Hospital of Harbin Medical University, Harbin
Shanghai eye disease prevention and control center, Shanghai
Shanghai General Hospital, Shanghai
Shanghai Jiao Tong University School of Medicine (SJTUSM) - XinHua Hospital, Shanghai
Eye & Ent Hospital of Fudan University, Shanghai
Nanjing First Hospital, Nanjing
Affiliated hospital of Nantong university, Nantong
The Second Hospital of Anhui medical university, Hefei
Jinan Second People's Hospital, Jinan
Eye hospital of Shandong First Medical University, Jinan
Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital, Shandong
Weifang Ophthalmology Hospital, Shandong
Tianjin Medical University Eye Hospital, Tianjin
Zhejiang University School of Medicine - The Second Affiliated Hospital, Hangzhou
Taizhou Hospital of Zhejiang Province, Taizhou
Eye Hospital of Wenzhou Medical University, Wenzhou
The First Affiliated Hospital of NanChang University, Nanchang
The Second Affiliated Hospital of Nanchang University, Nanchang
The First Affiliated Hospital of Chongqing Medical Universit, Chongqing
Central South University - The Second Xiangya Hospital, Changsha
Renmin Hosp., Wuhan Univ., Wuhan
Henan Provincial Eye Hospital, Henan
Zhengzhou Second People's Hospital, Erqi
Luoyang Third People's Hospital, Luoyang
Guangdong Provincial Hospital of TCM, Guangzhou
Guangzhou First People Hospital, Guangzhou
Zhujiang Hospital of Southern Medical University, Guangzhou
Guangzhou Aier Ophthalmology Hospital, Guangzhou
Joint Shantou International Eye Center (JSIEC)Shantou University & the Chinese University of Hong Kong, Shantou
The People's Hospital of Guangxi Zhuang Autonomous Region, Nanning
Chengdu Aier Ophthalmology Hospital, Chengdu
Chengdu University of Traditional Chinese Medicine - Teaching Hospital (Sichuan Province Traditional Chinese Medicine Hospital), Chengdu
Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an
Xianyang First People's Hospital, Xianyang
Lanzhou University Second Hospital, Lanzhou
People's Hospital of Ningxia Hui Autonomous Region - Opthalmology, Ningxia
Aier Eye Hospital (LIAONING), Shenyang
Shanxi Bethune Hospital, Taiyuan
Sichuan University West China Hospital, Chengdu
Hebei eye hospital, Hebei
Shanxi Eye Hospital, Shanxi
Shijiazhuang People's Hospital, Shijiazhuang
Grantham Hospital, Hong Kong
Lead Sponsor
Regeneron Pharmaceuticals
INDUSTRY
Bayer
INDUSTRY