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)
NCT ID: NCT05562947
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
68 participants
INTERVENTIONAL
2024-06-17
2029-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* Prior treatment with brolucizumab
* Prior gene therapy for nAMD or other ocular diseases
* Previous participation in any ocular disease studies of investigational drugs and/or devices, within 3 months or five elimination half-lives of the investigational therapy, 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 is greater 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 months prior 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 of myopia
* Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
* Intraocular surgery (including cataract surgery) within 3 months preceding the randomization visit
* Uncontrolled ocular hypertension or glaucoma
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* 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
50 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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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
Countries
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Central Contacts
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Reference Study ID Number: YR42983, https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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YR42983
Identifier Type: -
Identifier Source: org_study_id
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