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A Study of the Efficacy, Safety, and Pharmacokinetics (PK) of the Port Delivery System With Ranibizumab (PDS) in Chinese Participants With Neovascular Age-related Macular Degeneration (nAMD)
Sponsor: Hoffmann-La Roche
Summary
This study will evaluate the efficacy, safety, and PK of ranibizumab 100 milligrams per milliliter (mg/mL) delivered every 24 weeks (Q24W) via the PDS implant compared with ranibizumab 0.5 milligrams (mg) delivered every 4 weeks (Q4W) as intravitreal (IVT) injection in chinese participants with nAMD.
Official title: A Phase III, Multicenter, Randomized, Visual Assessor-masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Chinese Patients With Neovascular Age-related Macular Degeneration
Key Details
Gender
All
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2024-06-17
Completion Date
2029-08-30
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
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.
Locations (16)
Peking Union Medical College Hospital
Beijing, China
Beijing Hospital
Beijing, China
Beijing Tongren Hospital
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
Sichuan Provincial People's Hospital
Chengdu, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
Qingdao Eye Hospital of Shandong First Medical University
Qingdao, China
Shanghai First People's Hospital
Shanghai, China
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China
The First Affiliated Hospital of China Medical University
Shenyang, China
Shanxi Eye Hospital
Taiyuan, China
Tianjin Medical University Eye Hospital
Tianjin, China
Eye Hospital, Wenzhou Medical University
Wenzhou, China
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, China