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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• Initial diagnosis of nAMD within 9 months prior to the screening visit
• Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to the screening visit
• Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
• Availability of historical VA data prior to the first anti-VEGF treatment for nAMD up to the screening visit
• BCVA of 34 letters or better (20/200 or better approximate Snellen equivalent), using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters
• All subtypes of nAMD lesions are permissible
• Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by the central reading center of fundus photography (FP), fluorescein angiography (FA), indocyanine green angiography (ICGA), fundus autofluorescence (FAF), and optical coherence tomography (OCT) images
Locations
Other Locations
China
Beijing Hospital
WITHDRAWN
Beijing
Beijing Tongren Hospital
RECRUITING
Beijing
Peking Union Medical College Hospital
RECRUITING
Beijing
Sichuan Provincial People's Hospital
RECRUITING
Chengdu
West China Hospital, Sichuan University
RECRUITING
Chengdu
Zhongshan Ophthalmic Center, Sun Yat-sen University
RECRUITING
Guangzhou
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
Qingdao Eye Hospital of Shandong First Medical University
RECRUITING
Qingdao
Shanghai First People's Hospital
RECRUITING
Shanghai
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
RECRUITING
Shanghai
The First Affiliated Hospital of China Medical University
RECRUITING
Shenyang
Shanxi Eye Hospital
RECRUITING
Taiyuan
Tianjin Medical University Eye Hospital
RECRUITING
Tianjin
Eye Hospital, Wenzhou Medical University
RECRUITING
Wenzhou
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITING
Wuhan
Xi'an People's Hospital (Xi'an Fourth Hospital)
RECRUITING
Xi'an
Contact Information
Primary
Reference Study ID Number: YR42983, https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date:2024-06-17
Estimated Completion Date:2029-08-30
Participants
Target number of participants:68
Treatments
Experimental: Implant Arm
Participants will have the implant (pre-filled intraoperatively with ranibizumab 100 mg/mL) surgically inserted on Day 1. After Day 1, participants in the implant arm will attend monthly study visits, and receive implant refill-exchanges with ranibizumab 100 mg/mL at Week 24 and Week 48. At the Week 48 study visit, participants will move to the long -term extension phase of the study and continue receiving refill-exchanges Q24W until the end of study. Participants will attend monthly visits up to Week 96 and bi-monthly visits, thereafter.
Experimental: IVT Arm
Participants will receive IVT ranibizumab 0.5 mg injections starting on Day 1. Participants will receive IVT ranibizumab 0.5 mg Q4W until Week 44. At the Week 48 study visit, participants will receive the PDS implant (pre-filled intraoperatively with ranibizumab 100 mg/mL), move to the long-term extension phase of the study and receive Q24W refill exchanges until the end of study. If participants are unable to attend the Week 48 visit due to extenuating circumstances, they should return no later than the next scheduled visit (Week 52), when they will receive the PDS implant. Participants will attend monthly visits up to Week 96 and bi-monthly visits, thereafter.