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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) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

NCT05562947•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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•A. Prior Ocular Treatment Study Eye
•History of vitrectomy surgery, submacular surgery, or other surgical intervention, all for AMD
•Prior treatment with Visudyne, external-beam radiation therapy, or transpupillary thermotherapy
•Previous treatment with corticosteroid IVT injection
•Previous intraocular device implantation (not including intraocular lens implants)
•Previous laser (any type) used for age-related macular degeneration (AMD) treatment
•Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the randomization visit
•Prior treatment with intravitreal treatments for geographic atrophy
•Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
•Either Eye
+28 more criteria

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

Key Dates

Start Date

June 17, 2024

Primary Completion Date

July 27, 2027

Completion Date

August 30, 2029

Last Updated

February 2, 2026

Enrollment

ESTIMATED participants

Conditions

Neovascular Age-related Macular DegenerationnAMD

Interventions

PDS With Ranibizumab (100 mg/mL)

DEVICE

Ranibizumab (10 mg/mL)

DRUG

Contacts

Reference Study ID Number: YR42983, https://forpatients.roche.com/

CONTACT

888-662-6728 (U.S. and Canada)global-roche-genentech-trials@gene.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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)

Inclusion Criteria

Exclusion Criteria

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)

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