Actively Recruiting
A Phase IIIb Study Evaluating a 36-Week Refill Schedule of the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration
Led by Hoffmann-La Roche · Updated on 2026-05-26
250
Participants Needed
57
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hoffmann-La Roche
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the port delivery system PDS with ranibizumab, a drug used to treat neovascular age-related macular degeneration nAMD. This study evaluates how well the PDS works and its safety, along with patient-reported outcomes. The focus is on a 36-week refill schedule for the PDS implant delivering ranibizumab to participants with nAMD. This Phase IIIb, multicenter study aims to better understand this treatment approach for patients with this eye condition. Participants will have the PDS implant surgically inserted in the study eye on Day 1. The implant is pre-filled with ranibizumab at a concentration of 100 mgmL, delivering about a 2-milligram dose. Those who show signs of disease activity or receive supplemental ranibizumab injections before Week 24 will have refill exchanges every 24 weeks. Others will have refill exchanges every 36 weeks. The treatments include the implant and supplemental intravitreal ranibizumab injections if needed. During the study, participants will undergo assessments including measuring their best corrected visual acuity using the ETDRS chart at multiple timepoints, especially around Weeks 68 and 72. Researchers will also monitor eye thickness and the need for additional treatments. Patient preferences and adverse events related to the implant and drug will be tracked for up to about 19 months. This thorough monitoring helps evaluate both the safety and effectiveness of the PDS with ranibizumab over time.
CONDITIONS
Brief Title
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with neovascular age-related macular degeneration within 24 months before screening
- Received at least 3 anti-VEGF intravitreal injections for nAMD within 6 months before screening
- Shown a response to prior anti-VEGF treatment since diagnosis
- Available historical visual acuity data from diagnosis before first anti-VEGF treatment
- Available historical OCT image data from diagnosis before first anti-VEGF treatment
- Best corrected visual acuity of 34 letters or better using the ETDRS chart at 4 meters at screening and enrollment visits
You will not qualify if you...
- History of vitrectomy, submacular surgery, or other AMD eye surgery in the study eye
- Previous corticosteroid intravitreal injection in the study eye
- Previous intraocular device implantation in the study eye
- History of vitreous hemorrhage or rhegmatogenous retinal detachment in the study eye
- History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery in the study eye
- History of corneal transplant in the study eye
- Severe allergic or anaphylactic reactions to biologic agents or components of study treatments
- Prior participation in experimental nAMD therapy trials
- Prior treatment with brolucizumab or gene therapy for nAMD
- Subretinal hemorrhage involving the center of the fovea in the study eye
- Subfoveal fibrosis or subfoveal atrophy in the study eye
- CNV caused by other diseases like ocular histoplasmosis, trauma, or pathologic myopia
- Any concurrent intraocular condition needing surgery during the study or affecting results in the study eye
- Active intraocular inflammation or untreated retinal tears in the study eye
- Aphakia or absence of posterior capsule in the study eye
- Uncontrolled ocular hypertension or glaucoma in the study eye
- Severe eyelid or eye surface diseases
- Non-functioning or absent non-study eye
- Active or history of uveitis, keratitis, scleritis, endophthalmitis, or chronic blepharitis
- Suspected or active ocular/periocular infections
- Active thyroid eye disease
- Uncontrolled blood pressure
- Active or history of autoimmune diseases
- Recent stroke, atrial fibrillation, or myocardial infarction within 3 months before consent
- Confirmed active systemic infection
- Other diseases or conditions contraindicating ranibizumab or implant placement
- Use of systemic anti-VEGF agents
- Chronic oral corticosteroid use
- Active cancer within 12 months except certain treated cancers
Research Team
R
Reference Study ID Number: MR45625 https://forpatients.roche.com/
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