RecruitingPhase 3NCT05562947

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)

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


Sponsor

Hoffmann-La Roche

Enrollment

68 participants

Start Date

Jun 17, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized eye implant called the Port Delivery System (PDS) with ranibizumab — a device surgically placed in the eye that continuously delivers a medication to treat neovascular age-related macular degeneration (nAMD). nAMD is a serious eye condition where abnormal blood vessels grow under the retina and leak fluid, damaging central vision. The implant is designed to provide long-lasting treatment without frequent eye injections. You may be eligible if... - You are 50 years of age or older - You have been diagnosed with nAMD within the past 9 months - You have had at least 3 anti-VEGF injections in the past 6 months and your eye has responded to treatment - Your best-corrected visual acuity is 20/200 or better - Your eye media is clear enough for retinal imaging You may NOT be eligible if... - You have had vitrectomy or other AMD-specific eye surgeries - You have previously received brolucizumab or gene therapy for the eye - You have active intraocular inflammation, vitreous hemorrhage, or glaucoma - You have more than 8 diopters of myopia - You have had intraocular surgery within 3 months of enrollment - You have a history of uveitis in either eye Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEPDS 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.

DRUGRanibizumab (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

View Full Details on ClinicalTrials.gov

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NCT05562947


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