What is ranibizumab studying for neovascular age-related macular degeneration?

Ranibizumab is being studied to compare two ways of delivering the medication for neovascular age-related macular degeneration in Chinese adults. The study evaluates a surgical implant that releases ranibizumab over time versus regular eye injections, aiming to understand which method better maintains vision and eye health. This research is sponsored by Hoffmann-La Roche.

Who may be eligible for this neovascular age-related macular degeneration clinical trial?

Adults aged 50 or older with a recent diagnosis of neovascular age-related macular degeneration who have received at least three prior anti-VEGF injections could be eligible. Participants need sufficient vision in the study eye and must be able to attend regular study visits. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this neovascular age-related macular degeneration clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered by the study. Participants should consider these costs when deciding to join.

Actively Recruiting

Phase 3

Age: 50Years +

All Genders

ID05562947

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

Participants Needed

Research Sites

109 weeks

Total Duration

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 mgmL 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 mgmL 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

Age: 50Years +

All Genders

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

Research Team

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

Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

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