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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD

A Phase IIIb, Multicenter, Single-arm Study Assessing the Effectiveness, Safety and Patient Reported Outcomes of a 36-week Refill Exchange Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-related Macular Degeneration

A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD (NCT06847542) is a Phase 3 interventional studying Neovascular Age-related Macular Degeneration, sponsored by Hoffmann-La Roche. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Neovascular Age-related Macular Degeneration, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 250 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Neovascular Age-related Macular Degeneration subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Initial diagnosis of nAMD within 24 months prior to screening - 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 Who Should NOT Join This Trial: A. Prior Ocular Treatment 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Initial diagnosis of nAMD within 24 months prior to screening * 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: A. Prior Ocular Treatment 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

Treatments Being Tested

DEVICE

Susvimo PDS Implant

Ranizumab will be administered via a PDS implant per the schedule described in the arm.

DRUG

Ranibizumab

Participants will receive ranibizumab delivered through the PDS implant. Participants will receive ranibizumab, 0.5 mg IVT injections as a supplemental treatment.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Medizinische Universität Innsbruck
Innsbruck, Austria
Kepler Universitätskliniken GmbH - Med Campus III
Linz, Austria
Landesklinikum Mistelbach
Mistelbach, Austria
Klaudianova Nemocnice - Mlada Boleslav;Ophtalmology dpt
Mladá Boleslav, Czechia
Faculty Hospital Ostrava
Ostrava, Czechia
Aarhus Universitetshospital
Aarhus N, Denmark
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
CHU Strasbourg - Nouvel Hopital Civil
Strasbourg, France
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Universitätkslinikum Düsseldorf, Augenklinik
Düsseldorf, Germany
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Medizinische Hochschule Hannover, Klinik für Augenheilkunde
Hanover, Germany
Universitätsmedizin Rostock
Rostock, Germany
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Würzburg, Germany
"G.Gennimatas" General Hospital of Athens
Athens, Attica, Greece

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06847542), the sponsor (Hoffmann-La Roche), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06847542 clinical trial studying?

The purpose of this study is to evaluate the effectiveness, safety, and PROs of the port delivery system with ranibizumab 100 milligrams/milliliters (mg/mL) refilled every 36 weeks (Q36W) in participants with nAMD. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06847542?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06847542?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06847542. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06847542. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.