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    Summary
    EudraCT Number:2020-001313-20
    Sponsor's Protocol Code Number:WR42221
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-04-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2020-001313-20
    A.3Full title of the trial
    A PHASE IIIb, GLOBAL, MULTICENTER, RANDOMIZED, VISUAL ASSESSOR−MASKED STUDY OF THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF A 36-WEEK REFILL REGIMEN FOR THE PORT DELIVERY SYSTEM WITH RANIBIZUMAB IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION (VELODROME)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy, Safety, and Pharmacokinetics of A 36-Week Refill Regimen for the Port Delivery System with Ranibizumab in Patients with wet Age-Related Macular Degeneration (Velodrome)
    A.4.1Sponsor's protocol code numberWR42221
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffman-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffman-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffman-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRANIBIZUMAB
    D.3.2Product code RO4893594
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOcular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Yes
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neovascular age-related macular degeneration (nAMD)
    E.1.1.1Medical condition in easily understood language
    Wet AMD, is a form of advanced AMD that causes central visual loss, and remains a leading cause of visual impairment in the elderly
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of ranibizumab 100 mg/mL delivered via the port delivery system with ranibizumab (PDS) every 36 weeks (Q36W) compared with every 24 weeks (Q24W) on the basis of change from baseline in best-corrected visual acuity (BCVA) score averaged over Weeks 68 and 72
    E.2.2Secondary objectives of the trial
    ●Efficacy of ranibizumab 100mg/mL delivered via PDS Q36W vs Q24W on basis of change from baseline in BCVA score over time, proportion of patients with BCVA scor. of 69 letters/better/38 letters/worse over W68/72, and over time, proport. of pat. who prefer rani. deliv. via PDS compared with IntraVitreal Treatm., proport. of pat. with bilater. disease who report preferring rani. deliv. via PDS compared with fellow eye IVT, proport. of pat. who lose <1, <5, or gain >= 0 letters in BCVA score from baseline over time, change from baseline in Cter Pt Thickness and Ctral Subfield Thickness over time, up to and includ. W72, proport. of pat. who do not undergo suppl. treatm. with IVT rani. 0.5 mg before each refill-exch. procedure, mean overall treatm. satisfaction at W40 measured by the Macular Disease Treatm. Satisfaction Quest.●Safety, tolerability of rani. deliv. via PDS●Pharmacokinetic profile of rani. deliv. via PDS Q36W vs Q24W●Formation of anti-drug antibodies to rani. deliv. via PDS
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General Inclusion criteria
    ●Age >= 50 years
    ●For women of childbearing potential: agreement to remain abstinent or use contraception and must remain abstinent or use contraceptive methods with a failure rate of <1% per year during the study, within 28 days after the final intravitreal ranibizumab injection and for 1 year after the final implant refill-exchange procedure or implantation of the PDS
    Ocular inclusion criteria
    ●Initial diagnosis nAMD within 9 months prior to the screening visit
    ●Previous treatment with at least three anti- vascular endothelial growth factor (VEGF) intravitreal injections for nAMD per standard of care within 6 months prior to the screening visit
    ●Demonstrated response to prior anti-VEGF intravitreal treatment since diagnosis
    ●Availability of historical visual acuity data prior to the first anti-VEGF treatment for nAMD until the time of study enrollment
    ●BCVA of 34 letters or better, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters at screening and enrollment visits
    ●With any subtype of nAMD lesions
    o 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 analysis and grading by the central reading center of fundus photography, fluorescein angiography, fundus autofluorescence image, and OCT images
    E.4Principal exclusion criteria
    Prior Ocular Treatment
    o Study Eye
    ● History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD
    ● Prior treatment with Visudyne®, external-beam radiation therapy, or transpupillary thermotherapy
    ● Previous treatment with corticosteroid intravitreal injection, intraocular device implantation, previous laser used for AMD treatment
    ● Treatment with anti-VEGF agents other than ranibizumab within 1 month prior to the enrollment visit
    ● Concurrent conjunctival, Tenon's capsule, and/or scleral condition in the supero-temporal quadrant of the eye that may affect the implantation, subsequent tissue coverage, and refill-exchange procedure of the PDS implant
    o Either Eye
    ● Prior treatment with brolucizumab and participation in a clinical trial involving any anti-VEGF drugs, within 6 months prior to the enrollment visit
    CNV Lesion Characteristics
    ● Patients who meet any of the following exclusion criteria related to CNV lesion
    o Study Eye
    ● Subretinal hemorrhage that involves the center of the fovea, if the hemorrhage is greater than 0.5 disc area in size at screening
    ● Subfoveal fibrosis or subfoveal atrophy
    o Either Eye
    ● CNV due to other causes, such as ocular histoplasmosis, trauma, central serous chorio-retinopathy, or pathologic myopia
    Concurrent Ocular Conditions
    ● Patients who meet any of the following exclusion criteria related to concurrent ocular conditions
    o Study Eye
    ● 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
    ● History of pars plana vitrectomy surgery, vitreous hemorrhage, rhegmatogenous retinal detachment, retinal tears or peripheral retinal breaks within 3 months prior to the enrollment visit
    ● Aphakia or absence of the posterior capsule
    ● Spherical equivalent of the refractive error demonstrating more than 8 diopters of myopia
    ● Preoperative refractive error that exceeded 8 diopters of myopia, for patients who have undergone prior refractive or cataract surgery in the study eye
    ● Intraocular surgery within 3 months preceding the enrollment visit
    ● 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
    ● History of glaucoma-filtering surgery, tube shunts, or microinvasive glaucoma surgery
    ● History of corneal transplant
    o Fellow (Non-Study) Eye
    Patients who meet the following exclusion criterion for the fellow (non-study) eye at both the screening and enrollment visits will be excluded from study entry:
    ● Non-functioning study eye, defined as either:
    ● BCVA of hand motion or worse
    ● No physical presence of non-study eye (i.e., monocular)
    o Either Eye
    ● Any history of uveitis requiring treatment
    ● Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis
    Concurrent Systemic Conditions
    ● Uncontrolled blood pressure
    ● 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 within the last 3 months prior to informed consent, 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
    ● Confirmed active systemic infection
    ● Use of any systemic anti-VEGF agents
    ● 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 disease studies of investigational drugs within 1 month preceding the informed consent
    ● Use of antimitotic or antimetabolite therapy within 30 days or 5 elimination half-lives of the enrollment visit
    ● Pregnant or breastfeeding, or intending to become pregnant during the treatment period or within 1 year after the final refill-exchange procedure
    E.5 End points
    E.5.1Primary end point(s)
    Change from baseline in BCVA score averaged over Weeks 68 and 72, as assessed using the ETDRS chart starting at a distance of 4 meters
    E.5.1.1Timepoint(s) of evaluation of this end point
    Weeks 68 and 72
    E.5.2Secondary end point(s)
    1. Change from baseline in BCVA score over time (up to and including Week 72)
    2. Proportion of patients with BCVA score of 69 letters or better averaged over Weeks 68 and 72
    3. Proportion of patients with BCVA score of 69 letters or better over time
    4. Proportion of patients with BCVA score of 38 letters or worse averaged over Weeks 68 and 72
    5. Proportion of patients with BCVA score of 38 letters or worse over time
    6. Proportion of patients who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PDS PPPQ at Week 24, 40 and 72
    7. Proportion of patients with bilateral disease who report preferring ranibizumab 100 mg/mL delivered via the PDS compared with intravitreal treatment, as measured by the PPPQ at Week 24, 40 and 72
    8. Proportion of patients who lose <10, <5, or gain >= 0 letters in BCVA score from baseline averaged over Weeks 68 and 72
    9. Proportion of patients who lose <10, <5, or gain >= 0 letters in BCVA score from baseline over time
    10. Change from baseline in CPT up to and including Week 72
    11. Change from baseline in central subfield thickness (CST) over time , up to and including Week 72
    12. Proportion of patients who do not undergo supplemental treatment with intravitreal ranibizumab 0.5 mg before each refill-exchange procedure
    13. Mean overall treatment satisfaction at Week 40, as measured by the Macular Disease Treatment Satisfaction Questionnaire (MacTSQ) total score in the Q36W arm compared with the Q24W arm
    14. Incidence and severity of ocular and systemic adverse events in Q36W and Q24W
    15. Incidence, severity, and duration of adverse events of special interest, including ocular adverse events of special interest in Q36W and Q24W
    16. Incidence, severity, and duration of ocular adverse events of special interest during the postoperative period and follow-up period in all enrolled patients
    17. Observed serum concentration of ranibizumab at specified timepoints
    18. Incidence of treatment-emergent ADAs to ranibizumab during the study
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Week 72
    2. At Weeks 68 and 72
    3. Up to 22 months
    4. At Weeks 68 and 72
    5. Up to 22 months
    6-7. At Week 24, 40 and 72
    8. At Weeks 68 and 72
    9. Up to 22 months
    10. Baseline (enrolment visit up to 7 days before Day 1) to up to Week 72
    11. Up to Week 72
    12. Up to 22 months
    13. At Week 40
    14-16. Up to 22 months
    17. Day 1, Week 4, 12, 24, at study termination visit and at explanation visit; for Arm A and B (Q36W and Q24W): Week 36, 72 and at early study termination visit and at explanation visit
    18. Day 1, Week 4, 24 and at study termination visit, Arm A and B (Q36W and Q24W): Week 36, 72, at early study termination
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    immunogenicity, exploratory biomarker, exploratory patient experience
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Q24W versus Q36W
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA54
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Brazil
    Canada
    Israel
    Korea, Republic of
    Singapore
    Taiwan
    Austria
    Belgium
    France
    Germany
    Italy
    Spain
    Switzerland
    United Kingdom
    Argentina
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 380
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 442
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The sponsor will terminate the trial once Ranibizumab becomes commercially available. Currently, the Sponsor does not have any plans to provide Ranibizumab to patients who have completed the study. The Sponsor may evaluate whether to continue providing Ranibizumab in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website: http://www.roche.com/policy_continued_access_to_investigational_ medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-12-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-23
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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