Actively Recruiting
A Phase III Study of the Port Delivery System With Ranibizumab Compared to Ranibizumab Injections in Chinese Patients With Neovascular Age-related Macular Degeneration
Led by Hoffmann-La Roche · Updated on 2026-06-08
68
Participants Needed
16
Research Sites
109 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy, safety, and pharmacokinetics of ranibizumab delivered through a Port Delivery System (PDS) implant compared to ranibizumab injections in Chinese adults aged 50 and older with neovascular age-related macular degeneration (nAMD). The study aims to compare ranibizumab 100 mg/mL given every 24 weeks via the implant with ranibizumab 0.5 mg injections given every 4 weeks, focusing on visual acuity and ocular health outcomes. Participants are randomly assigned to one of two groups. One group receives a PDS implant pre-filled with ranibizumab 100 mg/mL surgically inserted on Day 1, followed by implant refill-exchanges every 24 weeks starting at Week 24 and continuing through a long-term extension phase. The other group receives monthly intravitreal injections of ranibizumab 0.5 mg until Week 44, then receives the PDS implant at Week 48, followed by similar refill-exchanges every 24 weeks. Study visits are monthly up to Week 96, then occur every two months until study completion. During the study, participants undergo regular assessments including visual acuity tests using the ETDRS chart, ocular imaging, and safety evaluations. Researchers monitor changes in best-corrected visual acuity, retinal thickness, and ocular adverse events. Blood samples will be collected to measure ranibizumab levels and immune responses. The trial includes monthly visits initially, transitioning to bi-monthly visits, extending up to the study end date in August 2029, to closely follow participants' response and safety.
CONDITIONS
Brief 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...
- Adults aged 50 years or older
- Initial diagnosis of neovascular age-related macular degeneration within 9 months before screening
- Received at least three anti-VEGF intravitreal injections for nAMD within 6 months prior to screening
- Demonstrated response to prior anti-VEGF treatment since diagnosis
- Availability of historical visual acuity data before 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 allowed
- Clear ocular media and adequate pupil dilation for retinal imaging and grading
You will not qualify if you...
- History of vitrectomy, submacular surgery, or other AMD-related surgical interventions in study eye
- Prior treatment with Visudyne, external-beam radiation, or transpupillary thermotherapy
- Previous corticosteroid intravitreal injections or implants
- Prior intraocular device implantation excluding lens implants
- Previous laser treatment for AMD
- Treatment with anti-VEGF agents other than ranibizumab within 1 month before randomization
- Prior intravitreal treatments for geographic atrophy
- Conjunctival, Tenon's capsule, or scleral conditions affecting implant procedures in study eye
- Prior treatment with brolucizumab or gene therapy for nAMD or other ocular diseases
- Recent participation in ocular investigational drug/device studies within 3 months or five drug half-lives
- Subretinal hemorrhage involving foveal center greater than 0.5 disc area
- Subfoveal fibrosis or atrophy
- CNV due to other causes such as ocular histoplasmosis or trauma
- Retinal pigment epithelial tear or active intraocular inflammation
- History of vitreous hemorrhage or retinal detachment
- Recent retinal tears or breaks within 3 months
- Aphakia or absence of posterior capsule
- High myopia over 8 diopters or prior refractive/cataract surgery with such error
- Intraocular surgery within 3 months
- Uncontrolled ocular hypertension or glaucoma
- History of glaucoma surgery or corneal transplant
- Non-functioning fellow eye
- History of uveitis or active eye infections such as conjunctivitis or keratitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks for initial treatment phase, then continuing with refill-exchanges in the long-term extension phase
Participants receive either the Port Delivery System implant with ranibizumab surgically inserted followed by refill-exchanges every 24 weeks, or ranibizumab injections every 4 weeks until Week 44. At Week 48, participants in the injection group receive the implant and then receive refill-exchanges every 24 weeks.
Monthly visits up to Week 96, then bi-monthly visits followed by visits every two months until study completion
Duration - Up to study completion at approximately 156 weeks
After initial treatment, participants continue receiving implant refill-exchanges every 24 weeks and attend follow-up visits to monitor safety and efficacy until the end of the study.
Bi-monthly visits followed by visits every two months until study completion
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/
F
Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry
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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