Actively Recruiting
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)
Led by Hoffmann-La Roche · Updated on 2026-05-01
68
Participants Needed
16
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Initial diagnosis of nAMD within 9 months prior to the screening visit
- Previous treatment with at least three anti-vascular endothelial growth factor (VEGF) intravitreal injections for nAMD within 6 months prior to screening
- Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
- Availability of historical visual acuity data prior to first anti-VEGF treatment
- Best-corrected visual acuity of 34 letters or better (20/200 or better approximate Snellen equivalent) using ETDRS chart at 4 meters
- All subtypes of nAMD lesions are allowed
- Clear ocular media and adequate pupil dilation for imaging analysis and grading by central reading center
You will not qualify if you...
- History of vitrectomy surgery, submacular surgery, or other surgical interventions for AMD in study eye
- Prior treatment with Visudyne, external-beam radiation, or transpupillary thermotherapy
- Previous corticosteroid intravitreal injection
- Previous intraocular device implantation (excluding intraocular lens implants)
- Previous laser treatment for AMD
- Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to randomization
- Prior intravitreal treatments for geographic atrophy
- Conjunctival, Tenon's capsule, or scleral conditions affecting implantation area
- Prior treatment with brolucizumab
- Previous gene therapy for nAMD or other ocular diseases
- Participation in ocular disease investigational studies within 3 months or five elimination half-lives
- Subretinal hemorrhage involving fovea >0.5 disc area at screening
- Subfoveal fibrosis or atrophy
- CNV due to other causes like ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia
- Retinal pigment epithelial tear or any concurrent intraocular condition
- Active intraocular inflammation grade trace or above
- History of vitreous hemorrhage or rhegmatogenous retinal detachment
- Retinal tears or breaks within 3 months prior to randomization
- Aphakia or absence of posterior capsule
- Refractive error exceeding 8 diopters of myopia
- Intraocular surgery within 3 months before randomization
- Uncontrolled ocular hypertension or glaucoma
- History of glaucoma surgery or corneal transplant
- Non-functioning fellow eye
- History of uveitis
- Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
Peking Union Medical College Hospital
Beijing, China, 100032
Actively Recruiting
2
Beijing Hospital
Beijing, China, 100730
Withdrawn
3
Beijing Tongren Hospital
Beijing, China, 100730
Actively Recruiting
4
West China Hospital, Sichuan University
Chengdu, China, 610041
Actively Recruiting
5
Sichuan Provincial People's Hospital
Chengdu, China, 610072
Actively Recruiting
6
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, China, 510060
Actively Recruiting
7
The Second Affiliated Hospital of Harbin Medical University
Harbin, China, 150081
Actively Recruiting
8
Qingdao Eye Hospital of Shandong First Medical University
Qingdao, China, 266109
Actively Recruiting
9
Shanghai First People's Hospital
Shanghai, China, 200080
Actively Recruiting
10
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, China, 200092
Active, Not Recruiting
11
The First Affiliated Hospital of China Medical University
Shenyang, China, 110001
Actively Recruiting
12
Shanxi Eye Hospital
Taiyuan, China, 030002
Actively Recruiting
13
Tianjin Medical University Eye Hospital
Tianjin, China, 300070
Actively Recruiting
14
Eye Hospital, Wenzhou Medical University
Wenzhou, China, 325027
Actively Recruiting
15
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
16
Xi'an People's Hospital (Xi'an Fourth Hospital)
Xi'an, China
Actively Recruiting
Research Team
R
Reference Study ID Number: YR42983, https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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