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Looking for participantsPhase3

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

Sponsor: Hoffmann-La Roche

NCT ID: NCT06847542

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Susvimo PDS Implant (device), Ranibizumab (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Susvimo PDS Implant — device: Ranizumab will be administered via a PDS implant per the schedule described in the arm. · Ranibizumab — drug: Participants will receive ranibizumab delivered through the PDS implant.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years and over
Who
All
Number of participants
250
Started
2025-11-27
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for neovascular age-related macular degeneration
  • • Phase3 - 250 participants
  • • 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

Who can take part?

  • • Ages 50 Years and over
  • • Diagnosed with neovascular age-related macular degeneration

Where?

  • • Leicester - Leicester Royal Infirmary
  • • Gloucester - Gloucestershire Royal Hospital
  • • London - Moorfields Eye Hospital NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

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.

Neovascular Age-related Macular Degeneration

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years and over
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ at least 3 anti-vascular endothelial growth fact

What the study is looking for

  • ✓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...
  • ✓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...
  • ✓Availability of historical OCT image data obtained at or after nAMD diagnosis and prior to the first anti-VEGF...

Who cannot take part

  • ✗A. Prior Ocular Treatment
  • ✗Study Eye:
  • ✗History of vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular...
  • ✗Previous treatment with corticosteroid intravitreal injection
  • ✗Previous intraocular device implantation
See the full criteria
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

Where Is This Study? (3 UK sites)

Leicester Royal Infirmary

Leicester LE1 5WW, United Kingdom

Recruiting
Hospital R&D contact (matched)

Carolyn Maloney

uhl-tr.researchandinnovationadminmailbox@nhs.net0116 258 8351

Gloucestershire Royal Hospital

Gloucester GL1 3NN, United Kingdom

Recruiting
Hospital R&D contact (matched)

R&I Professional Services

ghn-tr.glos.riprofessionalservices@nhs.net033 422 5467

Moorfields Eye Hospital NHS Foundation Trust

London EC1V 2PD, United Kingdom

Recruiting
Hospital R&D contact (matched)

Research Portfolio Managers- Daniela Narvaez, Anika Kadchha, Abi Chandrakumar, Xin Liu

moorfields.resadmin@nhs.net0207 566 2036

How to Get in Touch

Reference Study ID Number: MR45625 https://forpatients.roche.com/ No attachments to email below.

Sponsor contact

CONTACT

888-662-6728 (U.S.) global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-09