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)

Last updated: April 30, 2026
Sponsor: Hoffmann-La Roche
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

PDS With Ranibizumab (100 mg/mL)

PDS with ranibizumab (100 mg/mL)

Ranibizumab (10 mg/mL)

Clinical Study ID

NCT05562947
YR42983
  • Ages > 50
  • All Genders

Study 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 Criteria

Inclusion

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 thescreening visit

  • Demonstrated response to prior anti-VEGF IVT treatment since diagnosis

  • Availability of historical VA data prior to the first anti-VEGF treatment for nAMDup 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 startingdistance of 4 meters

  • All subtypes of nAMD lesions are permissible

  • Sufficiently clear ocular media and adequate pupillary dilation to allow foranalysis and grading by the central reading center of fundus photography (FP),fluorescein angiography (FA), indocyanine green angiography (ICGA), fundusautofluorescence (FAF), and optical coherence tomography (OCT) images

Exclusion

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 transpupillarythermotherapy

  • 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 therandomization visit

  • Prior treatment with intravitreal treatments for geographic atrophy

  • Concurrent conjunctival, Tenon's capsule, and/or scleral condition in thesupero-temporal quadrant of the eye that may affect the implantation, subsequenttissue coverage, and refill-exchange procedure of the PDS implant

Either Eye

  • Prior treatment with brolucizumab

  • Prior gene therapy for nAMD or other ocular diseases

  • Previous participation in any ocular disease studies of investigational drugs and/ordevices, within 3 months or five elimination half-lives of the investigationaltherapy, whichever is longer, preceding the screening visit

B. Choroidal Neovascularization (CNV) Lesion Characteristics

Study Eye

  • Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage isgreater than 0.5 disc area (1.27 millimeter square [mm^2]) in size at screening

  • Subfoveal fibrosis or subfoveal atrophy

Either Eye • CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia

C. Concurrent Ocular Conditions Study Eye

  • Retinal pigment epithelial tear

  • Any concurrent intraocular condition

  • Active intraocular inflammation (grade trace or above)

  • History of vitreous hemorrhage

  • History of rhegmatogenous retinal detachment

  • History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 monthsprior to the randomization visit

  • History of pars plana vitrectomy surgery

  • Aphakia or absence of the posterior capsule

  • Spherical equivalent of the refractive error demonstrating more than 8 diopters ofmyopia

  • Preoperative refractive error that exceeds 8 diopters of myopia, for participantswho have undergone prior refractive or cataract surgery

  • Intraocular surgery (including cataract surgery) within 3 months preceding therandomization visit

  • Uncontrolled ocular hypertension or glaucoma

  • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucomasurgery

  • History of corneal transplant

Fellow (Non-Study) Eye

• Non-functioning fellow eye

Either Eye

  • Any history of uveitis

  • Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis

Study Design

Total Participants: 68
Treatment Group(s): 3
Primary Treatment: PDS With Ranibizumab (100 mg/mL)
Phase: 3
Study Start date:
June 17, 2024
Estimated Completion Date:
August 30, 2029

Connect with a study center

  • Beijing Hospital

    Beijing, 100730
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing, 100730
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing, 100032
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing 1816670, 100730
    China

    Site Not Available

  • Beijing Tongren Hospital

    Beijing 1816670, 100730
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing 1816670, 100032
    China

    Active - Recruiting

  • Beijing Hospital

    Beijing City, 100006
    China

    Active - Recruiting

  • Peking Union Medical College Hospital

    Beijing City, 100032
    China

    Site Not Available

  • Sichuan Provincial People's Hospital

    Chengdu, 610072
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Active - Recruiting

  • Sichuan Provincial People's Hospital

    Chengdu 1815286, 610072
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu 1815286, 610041
    China

    Active - Recruiting

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, 510060
    China

    Active - Recruiting

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou 1809858, 510060
    China

    Site Not Available

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou City, 510060
    China

    Site Not Available

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin, 150081
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University; ophthalmology department

    Harbin, 150081
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Harbin Medical University

    Harbin 2037013, 150081
    China

    Site Not Available

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao, 266109
    China

    Active - Recruiting

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao 1797929, 266109
    China

    Site Not Available

  • Qingdao Eye Hospital of Shandong First Medical University

    Qingdao City, 266109
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai, 200080
    China

    Active - Recruiting

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, 200092
    China

    Site Not Available

  • Shanghai First People's Hospital

    Shanghai 1796236, 200080
    China

    Site Not Available

  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai 1796236, 200092
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang, 110001
    China

    Active - Recruiting

  • The First Affiliated Hospital of China Medical University

    Shenyang 2034937, 110001
    China

    Site Not Available

  • The First Affiliated Hospital of China Medical University

    Shenyang City, 110001
    China

    Site Not Available

  • Shanxi Eye Hospital

    Taiyuan, 030002
    China

    Active - Recruiting

  • Shanxi Eye Hospital

    Taiyuan 1793511, 030002
    China

    Site Not Available

  • Shanxi Eye Hospital

    Taiyuan City, 030002
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin, 300070
    China

    Active - Recruiting

  • Tianjin Medical University Eye Hospital

    Tianjin 1792947, 300070
    China

    Site Not Available

  • Tianjin Medical University Eye Hospital

    Tianjin City, 300070
    China

    Site Not Available

  • Eye Hospital, Wenzhou Medical University

    Wenzhou, 325027
    China

    Active - Recruiting

  • Eye Hospital, Wenzhou Medical University

    Wenzhou 1791388, 325027
    China

    Site Not Available

  • Eye Hospital, Wenzhou Medical University

    Wenzhou City, 325027
    China

    Site Not Available

  • Central Theater General Hospital of the Chinese People's Liberation Army

    Wuhan, 430012
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan 1791247, 430030
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430030
    China

    Site Not Available

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    XI An,
    China

    Site Not Available

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an,
    China

    Active - Recruiting

  • Xi'an People's Hospital (Xi'an Fourth Hospital)

    Xi'an 1790630,
    China

    Site Not Available

  • Xuzhou No.1 Peoples Hospital

    Xuzhou,
    China

    Site Not Available

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