A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
NCT ID: NCT06847542
Last Updated: 2025-12-30
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
250 participants
INTERVENTIONAL
2025-11-27
2028-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
* The best corrected visual acuity (BCVA) examiner will only conduct refraction and BCVA assessments and will be masked to participant study eye assignment and study visit type.
* The BCVA examiner will have no access to a participant's BCVA scores from previous visits and will be aware only of the participant's refraction data from previous visits.
* The BCVA examiner may provide no other direct or indirect participant care.
Study Groups
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Port Delivery System (PDS)
Participants will have the PDS implant (pre-filled with 100 mg/mL of ranibizumab) \[approximately 2-milligrams (mg) dose\] surgically inserted in the study eye on Day 1. Participants who meet the disease activity criteria (DAC) at Week 24 or receive supplemental treatment with intravitreal (IVT) injections of ranibizumab prior to Week 24 will receive implant refill exchanges every 24 weeks (Q24W). Participants who do not meet the DAC at Week 24 and have not received supplemental treatment will receive PDS refill exchanges Q36W.
Susvimo PDS Implant
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
Ranibizumab
Participants will receive ranibizumab delivered through the PDS implant.
Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
Interventions
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Susvimo PDS Implant
Ranizumab will be administered via a PDS implant per the schedule described in the arm.
Ranibizumab
Participants will receive ranibizumab delivered through the PDS implant.
Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previous treatment with at least 3 anti-vascular endothelial growth factor (VEGF) IVT injections for nAMD per standard of care within 6 months prior to screening
* Demonstrated response to prior anti-VEGF IVT treatment since diagnosis
* Availability of historical VA data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
* Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF treatment for nAMD
* BCVA of 34 letters or better using ETDRS chart at a starting distance of 4 meters at screening and enrollment visits
Exclusion Criteria
Study Eye:
* History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
* Previous treatment with corticosteroid intravitreal injection
* Previous intraocular device implantation
* History of vitreous hemorrhage
* History of rhegmatogenous retinal detachment
* History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
* History of corneal transplant
Either Eye:
* History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of the ranibizumab injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
* Prior participation in a clinical trial involving any experimental therapies for nAMD
* Prior treatment with brolucizumab or gene therapy for nAMD
B. Macular Neovascularization/Choroidal Neovascularization (MNV/CNV) Lesion Characteristics:
Study Eye:
* Subretinal hemorrhage that involves the center of the fovea
* Subfoveal fibrosis or subfoveal atrophy
Either Eye:
* CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorioretinopathy, or pathologic myopia
* CNV masquerading lesions
C. Concurrent Ocular Conditions:
Study Eye:
* Subfoveal and/or juxtafoveal retinal pigment epithelial tear
* Any concurrent intraocular condition that would either require surgical intervention during the study to prevent or treat visual loss that might result from that condition or affect interpretation of study results
* Active intraocular inflammation
* Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated or treated within 3 months prior to the enrollment visit
* Aphakia or absence of the posterior capsule
* Uncontrolled ocular hypertension or glaucoma
* History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
* Trichiasis
* Corneal neuropathy
* Lagophthalmos or incomplete blink
* Active or history of facial nerve palsy/paresis
Fellow (Non-study) Eye:
\- Non-functioning non-study eye defined as either: BCVA of hand motion or worse OR no physical presence of non-study eye (i.e., monocular)
Either Eye:
* Any active or history of uveitis
* Active or history of keratitis, scleritis, endophthalmitis, or chronic blepharitis
* Suspected or active ocular or periocular infectious conjunctivitis or endophthalmitis
* Active or history of floppy eyelid syndrome
* Active thyroid eye disease
D. Concurrent Systemic Conditions:
* Uncontrolled blood pressure
* Active or history of autoimmune diseases
* History of stroke within the last 3 months prior to informed consent
* Atrial fibrillation diagnosed or worsened within the last 3 months prior to informed consent
* History of myocardial infarction (MI) within the last 3 months prior to informed consent
* Confirmed active systemic infection
* History of other disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of ranibizumab or placement of the implant and that might affect interpretation of the results of the study
* Use of any systemic anti-VEGF agents
* Chronic use of oral corticosteroids
* Active cancer within 12 months of enrollment except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer
50 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
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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Medizinische Universität Innsbruck
Innsbruck, , Austria
Kepler Universitätskliniken GmbH - Med Campus III
Linz, , Austria
Landesklinikum Mistelbach
Mistelbach, , Austria
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Institut Ophtalmologique De l Ouest Jules Verne
Nantes, Paris, France
Hopital Edouard Herriot - CHU Lyon
Lyon, , France
Clinique Honore Cave
Montauban, , France
CHNO des Quinze Vingts
Paris, , France
CHU Poitiers - CHR La Miletrie
Poitiers, , France
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, , Germany
"G.Gennimatas" General Hospital of Athens
Athens, Attica, Greece
University General Hospital of Heraklion
Heraklon, , Greece
University Hospital of Larissa
Larissa, , Greece
Ospedale Isola Tiberina - Gemelli Isola;UOC Chirurgia Vitreoretinica
Rome, Lazio, Italy
MW-med
Krakow, Lesser Poland Voivodeship, Poland
Klinika Okulistyczna ?Jasne Blonia? Sp. z o. o.
?ód?, , Poland
OFTALMIKA Sp. z o.o
Bydgoszcz, , Poland
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, , Poland
Kyungpook National University Hospital
Daegu, , South Korea
Ajou University Medical Center
Gyeonggi-do, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Seoul St Mary's Hospital
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, , South Korea
Berner Augenklinik
Bern, , Switzerland
Kantonsspital St. Gallen
Sankt Gallen, , Switzerland
Leicester Royal Infirmary
Leicester, Leicestershire, United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Reference Study ID Number: MR45625 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S.)
Email: [email protected]
Other Identifiers
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2024-516924-32-00
Identifier Type: CTIS
Identifier Source: secondary_id
MR45625
Identifier Type: -
Identifier Source: org_study_id