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    Phase IV: Ranibizumab in Neovascular Age-related Macular Degeneration (Belvedere)

    Clinical Trial Overview Inclusion and Exclusion Criteria Study Site Locations Enrollment and Resources
    Clinical Trial Overview

    Clinical Trial Overview

    Recruiting

    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 (PDS)

    Objective

    This study will assess corneal endothelial cells in participants with nAMD treated with PDS refilled every 24 weeks (Q24W).

    Trial Design

    Primary Endpoints

    • Percent Change in Corneal Endothelial Cell Density (ECD) From Baseline at Week 48 in the Study Eye as Compared With the Fellow Eye, as Assessed by Specular Microscopy

    Secondary Endpoints

    • Percent Change in Corneal ECD From Baseline at Week 24 in the Study Eye as Compared With the Fellow Eye
    • Percent Change in the Coefficient of Variation (CV) of Corneal Endothelial Cell Area From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye
    • Percent Change in Hexagonal Cells (HEX) From Baseline at Weeks 24 and 48 in the Study Eye as Compared With the Fellow Eye
    • Percentage of Participants With Ocular Serious Adverse Events (SAEs) and Severity of SAEs
    • Percentage of Participants With Ocular Adverse Events of Special Interests (AESIs) and Severity of Ocular AESIs
    • Duration of Ocular AESIs
    • Percentage of Participants With Ocular AESIs During the Postoperative Period
    • Percentage of Participants With Ocular AESIs During the Intermediate Postoperative Period
    • Percentage of Participants With Ocular AESIs During the Follow-up Period
    • Percentage of Participants With Adverse Device Effects (ADEs)
    • Number of Participants with Anticipated Serious Adverse Device Effects (ASADEs) and Severity of ASADEs
    • Duration of ASADEs

    Ranibizumab

    Other names: Not Applicable

    Modality: Recombinant humanized monoclonal antibody fragment

    Disease/Condition: Neovascular Age-related Macular Degeneration

    View Molecule

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT04853251

    View on ClinicalTrials.gov
    Inclusion and Exclusion Criteria

    Inclusion and Exclusion Criteria

    Inclusion Criteria
    • Ocular Inclusion Criteria:
    • Diagnosis of nAMD prior to screening as determined by the investigator
    • 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 (VA) data and spectral-domain optical coherence tomography (SD-OCT). Additionally, fluorescein angiography or color fundus photography can both be used to support participant eligibility per protocol at investigator discretion
    • Availability of comprehensive historical anti-vascular endothelial growth factor (VEGF) injection data, including agent administered and date of administration from the time of diagnosis, or for at least 2 years prior to screening if diagnosis was made more than 2 years before screening
    • Response to at least two prior anti-VEGF IVT injections as determined by the investigator based on the following:
    • Overall decrease in nAMD disease activity detected on historical or screening OCT
    • Stable or improved best-corrected visual acuity (BCVA)
    • BCVA of 34 letters (approximate 20/200 Snellen equivalent) or better, using Early Treatment of Diabetic Retinopathy Study (ETDRS) 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
    • 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
    Exclusion Criteria
    • Prior Ocular Treatment
    • Study Eye:
    • Prior treatment with external-beam radiation therapy or transpupillary thermotherapy
    • Previous treatment with verteporfin injection (PDT) or corticosteroid IVT injection within 2 years of screening
    • Previous laser (except PDT as stated above) used for age related macular degeneration (AMD) treatment
    • History of corneal transplant
    • History of conjunctival surgery in the superotemporal quadrant
    • History of intraocular inflammation following anti-VEGF injection
    • Either Eye:
    • Previous PDS implantation
    • Previous intraocular surgery (including cataract surgery) within 6 months of study enrollment
    • Prior vitrectomy surgery, submacular surgery, or other surgical intervention for age-related macular degeneration (AMD)
    • Prior pars plana vitrectomy surgery
    • Previous intraocular device implantation, excluding intraocular lenses
    • History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
    • Prior participation in a clinical trial involving any intravitreal agents that are not approved at time of screening
    • Intraocular laser therapy, including selective laser trabeculoplasty, yttrium-aluminum garnet (YAG), prophylactic peripheral iridotomy within 1 year of screening, or YAG capsulotomy within 3 months of screening
    • Contact lens wear in either eye within 2 months of screening
    • Any prior penetrating ocular trauma
    • Any prior ocular blunt trauma affecting corneal or retinal health in the opinion of the investigator, or any ocular blunt trauma within 6 months of screening
    • History of corneal transplantation, including partial-thickness corneal grafts
    • Prior treatment with brolucizumab
    • Prior treatment with external-beam radiation therapy or brachytherapy
    • History of hypersensitivity to ranibizumab or any excipients of Susvimo
    • Macular Neovascularization Lesion (MNV) Characteristics
    • Study Eye:
    • Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5-disc area [1.27 square millimeters (mm^2)] in size
    • Subfoveal fibrosis or subfoveal atrophy
    • Either Eye:
    • MNV due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
    • MNV masquerading lesions (e.g., cone dystrophy, adult vitelliform dystrophy, pattern dystrophy)
    • Current or Historical Ocular Conditions
    • Study Eye:
    • Retinal pigment epithelial tear
    • Retinal tears or peripheral retinal breaks on depressed fundus exam that are untreated, or treated within the 3 months prior to study enrollment
    • Current vitreous hemorrhage
    • Current or history of retinal detachment
    • Previous violation of the posterior capsule is also an exclusion criterion unless it occurred as a result of YAG laser posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
    • Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia or evidence of pathologic myopia on depressed fundus examination
    • Preoperative refractive error that exceeds 8 diopters of myopia, for participants who have undergone prior refractive or cataract surgery
    • Spherical equivalent of the refractive error demonstrating more than 5 diopters of hyperopia
    • Preoperative refractive error that exceeds 5 diopters of hyperopia, for participants who have undergone prior refractive or cataract surgery
    • Uncontrolled ocular hypertension or glaucoma and any such condition the investigator determines may require a glaucoma-filtering surgery during a patient's participation in the study
    • Scleral pathology in the superotemporal quadrant (e.g., scleral thinning or calcification)
    • Conjunctival pathologies in the superotemporal quadrant
    • History or presence of severe posterior blepharitis, recurrent chalazia or hordeolum, severe dry eye syndrome, or severe allergic conjunctivitis
    • Ectropion, entropion or other impairment of the upper or lower eyelid impacting lid functionality needed to protect the ocular surface from exposure
    • Trichiasis
    • Corneal neuropathy
    • Lagophthalmos or incomplete blink
    • Active or history of facial nerve palsy/paresis
    • Fellow (Non-Study) Eye:
    • • Concurrent or history of PDS implantation
    • Either Eye:
    • Aphakia or absence of the posterior capsule
    • 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
    • Corneal ECD ≤1500 cells/mm2 in either eye at screening as determined by the independent reading center
    • Fuchs endothelial corneal dystrophy Grade ≥ 2
    • Previous corneal endothelial cell damage, including from blunt or surgical trauma
    • Any ocular condition that precludes obtaining an analyzable specular microscopy image
    • Active or history of corneal edema
    • Active or history of corneal dystrophies
    • Active or history of iridocorneal endothelial syndrome
    • Active or history of pseudoexfoliation syndrome
    • Active or history of herpetic keratitis or kerato-uveitis
    • Any active or history of uveitis
    • Active intraocular inflammation
    • Active or history of keratitis, scleritis, or endophthalmitis
    • Active ocular or periocular infection
    • Active or history of Sjogren's syndrome or keratoconjunctivitis sicca
    • Active or history of floppy eyelid syndrome
    • Active or history of chronic eye rubbing
    • Active thyroid eye disease
    • Concurrent Systemic Conditions:
    • History of uncontrolled blood pressure
    • Active or history of autoimmune diseases such as rheumatoid arthritis, lupus, granulomatosis with polyangiitis (Wegener's)
    • History of stroke within the last 3 months prior to screening
    • Uncontrolled atrial fibrillation within 3 months of screening
    • History of myocardial infarction within the last 3 months prior to screening
    • 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 or renders the patient at high risk of treatment complications, in the opinion of the investigator
    • Current active systemic infection
    • 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 with a Gleason score of ≤ 6 and a stable prostate-specific antigen for > 12 months
    • Previous participation in any non-ocular (systemic) disease studies of investigational drugs within 1 month prior to screening (excluding vitamins and minerals)
    • Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the screening visit
    • Requirement for continuous use of any medications or treatments indicated as prohibited therapy
    • Pregnant or breastfeeding, or intention to become pregnant during the study
    • Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT04853251

    View on ClinicalTrials.gov
    Study Site Locations

    Study Site Locations

    Explore the map to find active sites closest to your location or search by your ZIP code.

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT04853251

    View on ClinicalTrials.gov

    50 Results

      Enrollment and Resources

      Enrollment & Resources

      Enrollment

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

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      Phone

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      Email

      [email protected]

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      ADDITIONAL RESOURCES

      Contact an MSL
      Submit Medical Inquiry
      View Related Clinical Trials

      ID: NCT04853251

      View on ClinicalTrials.gov

      Resources

      ClinicalTrials.gov

      Learn more about this trial (NCT04853251) on ClinicalTrials.gov.

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      Information is consistent with ClinicalTrials.gov as of June 02, 2026. 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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      • AD
        Alzheimer's disease

      • ABC
        advanced breast cancer

      • bADLs
        Basic activities of daily living

      • ISLT
        International Shopping List Test

      • MCI
        Mild cognitive impairment

      • CV
        coefficient of variation

      • HEX
        cell hexagonality

      • nAMD
        neurovascular age-related macular degeneration

      • PDS
        Port Delivery System

      • Q24W
        once every 24 weeks

      • BMI
        Body mass index

      • HbA1c
        hemoglobin A1C

      • HOMA-IR
        Homeostasis Model Assessment of Insulin Resistance

      • NLM
        National Library of Medicine

      • QUICKI
        Quantitative Insulin Sensitivity Check Index

      • SC
        Subcutaneous

      • SGLT-2
        sodium-glucose cotransporter-2

      • SMBG
        Self-Monitored Blood Glucose

      • T1DM
        Type 1 Diabetes Mellitus

      • T2DM
        Type 2 diabetes mellitus

      • AE
        adverse events

      • AESI
        Adverse Events of Special Interest

      • MDD
        major depressive disorder

      • PHQ-9
        Patient Health Questionnaire-9

      • SAE
        serious adverse events

      • ABR
        Annualized Bleed Rate

      • CBR
        clinical benefit rate

      • CDK4/6i
        cyclin-dependent kinase 4 and 6 inhibitor

      • CNS
        central nervous system

      • CR
        complete response

      • DoR
        duration of response

      • ER
        estrogen receptor

      • HER2
        human epidermal growth factor receptor 2

      • HER2-
        human epidermal growth factor receptor 2-negative

      • HR
        hormone receptor

      • HR+
        hormone receptor-positive

      • HRQoL
        health-related quality of life

      • mut
        mutated

      • NIS
        non-interventional study

      • ORR
        objective response rate

      • OS
        overall survival

      • PFS
        progression-free-survival

      • PIK3CA
        phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha

      • PIK3CAm
        PIK3CA-mutated

      • PK
        pharmacokinetics

      • PROs
        patient-reported outcomes

      • SD
        stable disease

      • SoC
        standard of care

      • VWD
        von Willebrand disease

      • WHO
        World Health Organization

      • T2D
        Type 2 diabetes

      • T1D
        Type 1 Diabetes

      • ADA
        anti-drug antibody

      • DXA
        Dual-energy X-ray Absorptiometry

      • ASCVD
        atherosclerotic cardiovascular disease

      • FGF21
        fibroblast growth factor 21

      • SHTG
        severe hypertriglyceridemia

      • TG
        triglycerides

      • MASH
        metabolic dysfunction-associated steatohepatitis

      • NAFLD
        non-alcoholic fatty liver disease

      • NAS
        NAFLD Activity Score

      • NASH
        nonalcoholic steatohepatitis

      • pmMS
        partial modified Mayo

      • CD
        Crohn's disease

      • CMV
        cytomegalovirus

      • HIV
        human immunodeficiency virus

      • HBV
        Hepatitis B

      • HCV
        Hepatitis C

      • TB
        tuberculosis

      • UC
        ulcerative colitis

      • TL1A
        tumor necrosis factor-like ligand 1A

      • mMS
        modified Mayo Score

      • APS
        average daily abdominal pain scores in the past week

      • CDAI
        Crohn’s Disease Activity Index

      • IBDQ
        Inflammatory Bowel Disease Questionnaire

      • SF
        stool frequency subscore

      • PBO
        Placebo

      • EASI
        Eczema Area and Severity Index

      • IGA
        Investigator Global Assessment

      • NRS
        Numerical Rating Scale

      • IM
        intramuscular

      • IL
        intralesional

      • PDE-4
        Phosphodiesterase-4

      • ACE
        angiotensin-converting enzyme

      • ARBs
        angiotensin II receptor blockers

      • ASO
        Antisense Oligonucleotide

      • CKD-EPI
        Chronic Kidney Disease Epidemiology Collaboration

      • eGFR
        Estimated Glomerular Filtration Rate

      • FACIT-F
        Functional Assessment of Chronic Illness Therapy-Fatigue subscale

      • g/day
        gram per day

      • g/g
        gram per gram

      • GIP
        Glucose-dependent Insulinotropic Polypeptide

      • GLP-1
        Glucagon-like Peptide-1

      • IgAN
        IgA nephropathy

      • mg/day
        milligrams per day

      • TEAEs
        Treatment-Emergent Adverse Events

      • UPCR
        Urine Protein-to-Creatinine Ratio

      • AEs
        Adverse events

      • ALT
        Alanine aminotransferase

      • AST
        Aspartate aminotransferase

      • C-SSRS
        Columbia-Suicide Severity Rating Scale

      • DMT
        Disease-modifying therapy

      • ECG
        Electrocardiogram

      • EDSS
        Expanded Disability Status Scale

      • Gd
        Gadolinium

      • IPMSSG
        International Pediatric Multiple Sclerosis Study Group

      • MRI
        Magnetic resonance imaging

      • MS
        Multiple sclerosis

      • PD
        Pharmacodynamic

      • PPMS
        Primary progressive multiple sclerosis

      • RMS
        Relapsing multiple sclerosis

      • SI
        Suicidal ideation

      • SPMS
        Secondary progressive multiple sclerosis

      • CYP3A4
        cytochrome-p450-3a4

      • ADAS-Cog-13
        Alzheimer's Disease Assessment Scale-Cognition 13

      • ADAs
        Anti-drug antibodies

      • ADCS-ADL
        Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory

      • ARIA
        Amyloid-related imaging abnormalities

      • CDR-GS
        Clinical Dementia Rating, Global Score

      • CDR-SB
        Clinical Dementia Rating, Sum of Boxes

      • CSF
        Cerebrospinal fluid

      • GFAP
        Glial fibrillar acidic protein

      • iADRS
        Integrated Alzheimer's Disease Rating Scale

      • IRR
        Infusion-related reactions

      • MMSE
        Mini-Mental State Examination

      • PET
        Positron emission tomography

      • RBANS DMI
        Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index

      • EORTC QLQ-C30
        European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire

      • PRO-CTCAE
        Patient-Reported Outcomes Common Terminology Criteria for Adverse Events

      • TTCD
        Time to Confirmed Deterioration

      • AJCC
        American Joint Committee on Cancer Staging System

      • ECOG
        Eastern Cooperative Oncology Group

      • FFPE
        formalin-fixed, paraffin-embedded

      • RECIST
        Response Evaluation Criteria in Solid Tumors

      • NSCLC
        non-small cell lung cancer

      • BICR
        blinded independent central review

      • CD137
        Cluster of Differentiation 137

      • EORTC QLQ-LC13
        European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire-Supplemental Lung Cancer Module

      • KRAS G12C
        Kirsten rat sarcoma viral oncogene homolog G12C

      • PD-L1
        Programmed death-ligand 1

      • RAS
        RAt Sarcoma

      • RT
        Radiation therapy

      • DOCR
        duration of complete response

      • DFS
        disease-free survival

      • EFSeff
        event-free survival efficacy causes

      • FACT-Lym LymS
        lymphoma subscale within the functional assessment of cancer therapy-Lymphoma questionnaire

      • IPI
        international prognostic index

      • IRF
        Independent Review Facility

      • Pola-R-CHP
        polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone

      • LBCL
        large B-cell lymphoma

      • PROMIS-29
        Patient-Reported Outcomes Measurement Information System-29

      • ESR1nmd
        ESR1 no-mutation-detected

      • IV
        4

      • II
        2

      • ECD
        endothelial cell density

      • III
        3

      +