68
Participants
Start Date
June 17, 2024
Primary Completion Date
July 27, 2027
Study Completion Date
August 30, 2029
PDS With Ranibizumab (100 mg/mL)
Participants randomized to the implant arm will have the implant (filled prior to implantation with approximately 20 microliters (μL) of the 100-mg/mL formulation of ranibizumab \[approximately 2 mg dose of ranibizumab\]) surgically inserted in the study eye at the Day 1 visit following their randomization visit, or at Week 48 visit for participants randomized to the IVT arm. After the initial fill of the implant with ranibizumab, participants will receive implant refill-exchanges at fixed 24-week intervals.
Ranibizumab (10 mg/mL)
Participants in the IVT arm will receive their first IVT injection of 50 μL of the 10 mg/mL ranibizumab (0.5 mg dose) at the Day 1 visit, which will occur at the conclusion of the randomization visit. Afterward, participants will receive IVT ranibizumab injections of 50 μL of the 10 mg/mL formulation Q4W at each scheduled study visit until Week 44.
RECRUITING
Peking Union Medical College Hospital, Beijing
WITHDRAWN
Beijing Hospital, Beijing
RECRUITING
Beijing Tongren Hospital, Beijing
RECRUITING
The First Affiliated Hospital of China Medical University, Shenyang
RECRUITING
The Second Affiliated Hospital of Harbin Medical University, Harbin
RECRUITING
Shanghai First People's Hospital, Shanghai
RECRUITING
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai
RECRUITING
Qingdao Eye Hospital of Shandong First Medical University, Qingdao
RECRUITING
Tianjin Medical University Eye Hospital, Tianjin
RECRUITING
Eye Hospital, Wenzhou Medical University, Wenzhou
RECRUITING
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan
RECRUITING
Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou
RECRUITING
West China Hospital, Sichuan University, Chengdu
RECRUITING
Sichuan Provincial People's Hospital, Chengdu
RECRUITING
Shanxi Eye Hospital, Taiyuan
RECRUITING
Xi'an People's Hospital (Xi'an Fourth Hospital), Xi'an
Hoffmann-La Roche
INDUSTRY