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    Phase IV: Port Delivery System with Ranibizumab in nAMD (BELVEDERE)

    Clinical Trial Overview

    A Phase IV, Multicenter, Open-Label Study to Assess Corneal Endothelial Cells in Patients with Neovascular Age-Related Macular Degeneration Treated with the Port Delivery System with Ranibizumab

    Objective

    This study will assess corneal endothelial cells in patients with neovascular age-related macular degeneration (nAMD) treated with Port Delivery System with ranibizumab (PDS) refilled every 24 weeks (Q24W).

    Trial Design

    Primary Endpoints

    • Percent change in corneal ECD from baseline at Week 48 assessed by specular microscopy

    Secondary Endpoints

    • Percent change in corneal ECD from baseline at Week 24
    • Percent change in the CV (Coefficient of Variation) of corneal Endothelial Cell Area from baseline at Weeks 24 and 48
    • Percent change in HEX from baseline at Weeks 24 and 48
    • Percentage of patients with ocular serious adverse events, adverse events of special Interests, and adverse device effects
    • Duration of ocular AESIs (Adverse Events of Special Interests)
    • Percentage of patients with ocular AESIs during the postoperative period, intermediate postoperative period, and follow-up period
    • Number of patients with and duration of ASADEs (Anticipated Serious Adverse Device Effects)

    Ranibizumab

    Modality: Recombinant humanized monoclonal antibody fragment

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    View on ClinicalTrials.gov

    Inclusion and Exclusion Criteria

    Key Inclusion Criteria Key Exclusion Criteria
    • Initial diagnosis of nAMD within 18 months prior to screening
    • Difference of <10% in ECD at screening between the 2 eyes as measured by specular microscopy and determined by the independent reading center
    • Availability of historical visual acuity data and SD-OCT (Spectral Domain Optical Coherence Tomography) imaging prior to the first anti-VEGF IVT (Intravitreal) treatment for nAMD
    • Demonstrated response to at least two anti-VEGF intravitreal injections since diagnosis
    • BCVA (Best corrected visual acuity) of 34 letters (approximate 20/200 Snellen equivalent) or better, using ETDRS (Early Treatment Diabetic Retinopathy Study) chart at a starting distance of 4 meters at screening and enrollment
    • All subtypes of nAMD lesions are permissible
    • nAMD lesions at the time of diagnosis must involve the macula (6 mm diameter centered at the fovea)
    • Sufficiently clear ocular media and adequate pupillary dilation to allow for clinical examination and analysis and grading by the central reading center of SD-OCT images
    • Prior treatment with verteporfin for injection, external-beam radiation therapy, transpupillary thermotherapy, or brachytherapy
    • Previous treatment with corticosteroid IVT injection, PDS implantation, or laser (any type) used for AMD treatment
    • Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
    • Corneal ECD ≤1500 cells/mm2 in either eye at screening as determined by the independent reading center
    • History of conjunctival surgery in the superotemporal quadrant, vitreous hemorrhage, rhegmatogenous retinal detachment, or corneal transplant
    • Previous intraocular device implantation excluding intraocular lenses
    • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
    • Contact lens wear in either eye within 2 months of screening
    • Any prior ocular trauma (blunt or penetrating)
    • History of corneal transplantation, including partial-thickness corneal grafts
    • Prior treatment with brolucizumab, any anti-VEGF biosimilar agents, faricimab, or aflibercept 8 mg within 2 months of screening

    Enrollment & Resources

    Enrollment

    For more information on eligibility criteria, view the study or reach out to our team.

    General icon

    Web

    ClinicalTrials.gov
    Identifier: NCT04853251

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    Phone

    1-888-662-6728
    (US and Canada)

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    Email

    [email protected]

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    Clinical Trial Site Locations

    Clinical Trial Site Locations

    For more information on recruitment status, or where the study is being conducted

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    Patient Resources

    Genentech offers a place for patients, relatives, and caregivers to learn more about clinical trials.

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    Information is consistent with ClinicalTrials.gov as of September 15, 2025. Products under investigation have not been approved for use outside of the clinical trial setting. This information is presented only for the purposes of providing an overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved purposes.

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    TOP

    • CV
      coefficient of variation

    • ECD
      endothelial cell density

    • HEX
      cell hexagonality

    • nAMD
      neurovascular age-related macular degeneration

    • PDS
      Port Delivery System

    • Q24W
      once every 24 weeks