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    Phase III: Ranibizumab in Diabetic Macular Edema (Pagoda)

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

    Clinical Trial Overview

    Active, not recruiting

    A Phase III, Multicenter, Randomized, Visual Assessor-Masked, Active-comparator Study of the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Patients With Diabetic Macular Edema (Pagoda)

    Objective

    This study will evaluate the efficacy, safety, and Pharmacokinetics (PK) of the PDS with ranibizumab in participants with DME when treated every 24 weeks (Q24W) compared with intravitreal (IVT) ranibizumab 0.5 milligrams (mg) every 4 weeks (Q4W). The substudy will evaluate safety of re-implanting the updated PDS with ranibizumab and the refill-exchange procedures following re-implantation in participants with DME who were previously enrolled in the main study, GR40550. Up to 100 participants from the main study will be enrolled and followed for a maximum of 72 weeks post-re-implantation in the substudy.

    Primary Endpoints

    • Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured Using the ETDRS Chart in the Efficacy Population Using a Treatment Policy Strategy for all Intercurrent Events
    • Substudy: Number of Participants With Ocular and Systemic (Non-ocular) Adverse Events (AEs) and Severity of Ocular and Systemic AEs
    • Substudy: Number of Participants With Adverse Events of Special Interests (AESIs) and Severity of AESIs
    • Substudy: Duration of AESIs
    • Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Post-operative Period
    • Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs During the Follow-up Period
    • Substudy: Duration of Ocular AESIs During the Post-operative Period
    • Substudy: Duration of Ocular AESIs During the Follow-up Period
    • Substudy: Number of Participants With Adverse Device Effects (ADEs) and Severity of ADEs
    • Substudy: Number of Participants With Anticipated Serious ADEs
    • Substudy: Duration of Serious ADEs
    • Substudy: Number of Device Deficiencies

    Secondary Endpoints

    • Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the Modified Intent-to-treat (mITT) Population Using a Treatment Policy Strategy for All Intercurrent Events
    • Change in BCVA Score From Baseline Averaged Over Weeks 60 and 64 as Measured With Use of the ETDRS Chart in the mITT Population Using a Hypothetical Strategy for All Intercurrent Events
    • Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS at Week 64 in the Efficacy Population
    • Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS at Week 64 in the mITT population
    • Change from Baseline in BCVA as Measured on the ETDRS Chart Over Time
    • Percentage of Participants Who Lose <15, <10, and <5 letters in BCVA From Baseline Over Time
    • Percentage of Participants Who Gain ≥15, ≥10, ≥5, ≥0 Letters in BCVA From Baseline Over Time
    • Percentage of Participants With a BCVA Snellen Equivalent of 20/40 or Better Over Time
    • Percentage of Participants With a BCVA Snellen Equivalent of 20/200 or Worse Over Time
    • Percentage of Participants With a ≥2-step Improvement From Baseline on the ETDRS-DRSS Over Time
    • Percentage of Participants With a ≥3-step Improvement From Baseline on the ETDRS-DRSS Over Time
    • Time to ≥2-step Worsening From Baseline on the ETDRS-DRSS
    • Time to ≥3-step Worsening From Baseline on the ETDRS-DRSS
    • Change From Baseline in ETDRS-DRSS Score Over Time
    • Change From Baseline in Central Subfield Thickness (CST) as Measured on Spectral Domain Optical Coherence Tomography (SD-OCT) Over Time
    • Change From Baseline in Total Macular Volume as Measured on SD-OCT Over Time
    • Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time (IRF as Measured in the Central 1 mm Subfield)
    • Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time (SRF as Measured in the Central 1 mm Subfield)
    • Percentage of Participants With Absence of IRF and SRF Over Time
    • Percentage of Participants With Absence DME (Defined as CST ≥325 μm on SD-OCT) Over Time
    • Time to PDR (Defined as a Score ≥60 on the ETDRS-DRSS)
    • Percentage of Participants Who do not Undergo Supplemental Treatment With IVT Ranibizumab Within Each Refill-exchange Interval
    • Percentage of Participants Who Report Preferring PDS Treatment Compared With IVT Ranibizumab Treatment
    • Percentage of Participants Who Report Preferring PDS Treatment Compared With IVT Ranibizumab Treatment, as Measured by the PPPQ at Week 64
    • Participant-reported Vision-related Functioning and Health-Related Quality of Life (HRQoL) Among Participants in Both Treatment Arms, as Measured by Changes From Baseline
    • Participant-reported Vision-related Functioning and HRQoL, as Measured by the Proportion of Participants With a ≥ 4-Point Improvement From Baseline in the NEI VFQ-25 Composite Score at Weeks 48 and 96 Among Participants in Both Treatment Arms
    • Incidence and Severity of Ocular AEs
    • Incidence and Severity of Non-ocular AEs
    • Incidence, Severity, and Duration of AEs of Special Interest
    • Serum Concentration of Ranibizumab Observed Over Time
    • PK Parameter: Value Area Under the Concentration- Time Curve Over 24 weeks (AUC24W)
    • PK Parameter: Maximum Serum Concentration (Cmax)
    • PK Parameter: Minimum Serum Concentration (Cmin)
    • Time of Maximum Observed Serum Concentration (Tmax) After PDS Implant Insertion
    • Prevalence of Anti-drug Antibodies (ADAs) at Baseline and Incidence of ADAs During the Study
    • Prevalence of Neutralizing Antibodies at Baseline and Incidence of Neutralizing Antibodies During the Study
    • Reported Incidence of Device Deficiencies
    • Incidence and Severity of Ocular AEs
    • Incidence, Severity, and Duration of AESIs
    • Incidence, Severity, and Duration of Ocular AESIs During the Postoperative Period (up to 37 Days After Initial Implantation) and Follow-up Period (> 37 days After Implantation Surgery)
    • Incidence and Severity of ADEs
    • Incidence, Causality, Severity, and Duration of Anticipated Serious ADEs
    • Substudy: Number of Participants With Ocular AESIs and Severity of Ocular AESIs After Refill-exchange Procedure
    • Substudy: Duration of AESIs After Refill-exchange Procedure
    • Substudy: Number of Participants With ADEs and Severity of ADEs After Refill-exchange Procedure
    • Substudy: Number of Participants With Anticipated Serious ADEs After Refill-exchange Procedure
    • Substudy: Duration of Serious ADEs After Refill-exchange Procedure
    • Substudy: Number of Device Deficiencies After Refill-exchange Procedure

    Ranibizumab

    Other names: RG6321; RO4893594

    Modality: Recombinant humanized monoclonal antibody fragment

    Disease/Condition: Diabetic Macular Edema

    View Molecule

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT04108156

    View on ClinicalTrials.gov
    Inclusion and Exclusion Criteria

    Inclusion and Exclusion Criteria

    Inclusion Criteria
    • Age ≥18 years at time of signing informed consent form (ICF)
    • Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
    • Glycated haemoglobin (HbA1c) level of ≤10% within 2 months prior to screening or at screening
    • Study eye
    • Macular thickening secondary to DME involving the center of the fovea with CST ≥325 micrometer (µm) on SD-OCT at screening
    • BCVA score of 78 to 25 letters (20/32 to 20/320 approximate Snellen equivalent)
    • Having experienced a septum dislodgement in the original implant while in the main study or after exiting the main study
    • Sufficiently clear ocular media and adequate pupillary dilation to allow for analysis and grading by central reading center
    Exclusion Criteria
    • High-risk PDR
    • Active intraocular inflammation (grade trace or above)
    • Suspected or active ocular or periocular infection of either eye
    • 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
    • Cerebrovascular accident or myocardial infarction within 6 months prior to randomization
    • Atrial fibrillation diagnosis or worsening within 6 months prior to randomization
    • Uncontrolled blood pressure
    • Substudy:
    • Exclusion Criteria (Cohort 1 Only):
    • Recent history (in the last 3 months prior to enrollment) of other disease, other non-diabetic metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of ranibizumab or surgical placement of the PDS implant; that might affect interpretation of the results of the study; or that renders the participant at high risk for treatment complications
    • Active cancer within the last 12 months, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or prostate cancer
    • Current systemic treatment for a confirmed active systemic infection
    • Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals or enrollment in Study GR40550) within 6 months prior to enrollment
    • Use of antimitotic or antimetabolite therapy within 30 days
    • Ocular Exclusion Criteria for Study Eye:
    • Any ocular condition that may render the participant at high risk for surgical or treatment complications
    • Intraocular surgery (including cataract surgery) within 1 month preceding the enrollment visit
    • Any use of medicated intraocular implants (other than the PDS implant), at any time prior to enrollment
    • History of rhegmatogenous retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
    • Any concurrent ocular condition that would require surgical intervention during the study to prevent or treat visual loss
    • Concurrent conjunctival, tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye (e.g., scarring, thinning, mass) that may affect the refill-exchange procedure of the PDS implant
    • Ongoing ocular complications that might affect participant safety Ocular Exclusion Criteria for Either Eye
    • Suspected or active ocular or periocular infection (e.g., infectious conjunctivitis or endophthalmitis)
    • Any history of uveitis
    • Active blepharitis

    ADDITIONAL RESOURCES

    Contact an MSL
    Submit Medical Inquiry
    View Related Clinical Trials

    ID: NCT04108156

    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: NCT04108156

    View on ClinicalTrials.gov

    88 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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      ADDITIONAL RESOURCES

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      View Related Clinical Trials

      ID: NCT04108156

      View on ClinicalTrials.gov

      Resources

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      Learn more about this trial (NCT04108156) on ClinicalTrials.gov.

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      Information is consistent with ClinicalTrials.gov as of July 31, 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

      • 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
        Intraretinal Fluid

      • 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
        intravenous

      • II
        2

      • ECD
        endothelial cell density

      • III
        3

      • SC
        Subcutaneous

      +