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RECRUITING
NCT05562947
PHASE3

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

View on ClinicalTrials.gov

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

DEVICE

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.

DRUG

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