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    The EU Clinical Trials Register currently displays   42891   clinical trials with a EudraCT protocol, of which   7066   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-001421-55
    Sponsor's Protocol Code Number:CRFB002GFR02
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-09-22
    Trial results View 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 number2013-001421-55
    A.3Full title of the trial
    An open-label Extended Clinical Protocol of ranibizumab to evaluate Safety and Efficacy in rare VEGF driven ocular diseases.
    A.3.2Name or abbreviated title of the trial where available
    ECLIPSE
    A.4.1Sponsor's protocol code numberCRFB002GFR02
    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 SponsorNovartis Pharma S.A.S
    B.1.3.4CountryFrance
    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 supportNovartis Pharma S.A.S
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma S.A.S
    B.5.2Functional name of contact pointInformation&Communication Médicales
    B.5.3 Address:
    B.5.3.1Street Address2-4 rue Lionel Terray
    B.5.3.2Town/ cityRueil Malmaison
    B.5.3.3Post code92500
    B.5.3.4CountryFrance
    B.5.4Telephone number0033155476600
    B.5.5Fax number0033155476100
    B.5.6E-mailicm.phfr@novartis.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 Yes
    D.2.1.1.1Trade name Lucentis
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameLucentis
    D.3.2Product code RFB002A
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal 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.3.9.2Current sponsor codeRFB002
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit µl microlitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 No
    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 Yes
    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
    Choroidal neovascularization not related to wet Age-related macular degeneration (wAMD), pathologic myopia (PM)or Pseudoxanthoma elasticum (PXE), as well as in Macular Edema (ME) not related to Retinal Vein Occlusion (RVO) or Diabetic macular edema (DME) and other ocular neovascularization and/or complication such as Rubeosis Iridis and Neovacular Glaucoma and Proliferative Diabetic Retinopathy requiring Vitrectomy
    E.1.1.1Medical condition in easily understood language
    VGEF driven ocular diseases
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level HLGT
    E.1.2Classification code 10047060
    E.1.2Term Retina, choroid and vitreous haemorrhages and vascular disorders
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the 2-year safety of ranibizumab as assessed by type, rate and severity of serious and non-serious, ocular and non-ocular adverse events.
    E.2.2Secondary objectives of the trial
    •To describe ranibizumab efficacy at 3 months as assessed by suitable endpoint for each disease category over all monthly post-baseline assessments from Month 1 to Month 3:
    oBest-corrected visual acuity change (BVCA) for diseases affecting the macular area either through Choroidal neovascularization (CNV) or Macular edema (ME)
    oChange of the extent of iris neovascularization using “Teich and Walsh grading system” using iris photography for Rubeosis Iridis (RI) and Neovacular Glaucoma (NVG)
    oOccurrence of postoperative vitreous cavity hemorrhage for Proliferative Diabetic Retinopathy requiring Vitrectomy (RDP/V).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Male and female patients (≥ 18 years old)
    Patient with diagnosis of:
    •Active choroidal neovascularization (CNV) secondary to any causes (except wAMD, PM and PXE), involving the center of the fovea, confirmed by complete ocular examination of the study eye
    •Active macular edema (ME) confirmed by complete ocular examination of the study eye, secondary to any causes:
    oExcluding DME and RVO.
    oIncluding non infectious uveitis, non responder or with contraindication to dexamethasone (Ozurdex®) according to investigator’s judgment
    •Rubeosis iridis/neovascular glaucoma.
    •Proliferative diabetic retinopathy requiring vitrectomy.
    •Visual loss should only be due to the presence of any eligible type of CNV or to any eligible ME or to RI/NVG or to PDR/V based on ocular clinical, as well as FA and OCT and/or ICGA findings.
    And/or
    •Diagnosis of disease activity is based on investigator judgment:
    •CNV: presence of posterior pole changes compatible with active CNV (e.g. sub- or intraretinal fluid, hemorrhage), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography; presence of active leakage from CNV seen by fluorescein angiography (FA) and/or ICGA; presence of intra- or subretinal fluid/hemorrhage seen by optical coherence tomography (OCT)
    •ME: presence of posterior pole changes compatible with active ME (e.g. sub-retinal fluid), seen by fundus ophthalmoscopy, biomicroscopy and fundus photography; presence of active leakage from ME seen by fluorescein angiography (FA); presence of intra-retinal fluid/cysts seen by optical coherence tomography (OCT).
    •Rubeosis iridis, NVG: surface neovascularization extension ≥ stade 1 of “Teich and Walsh grading system” seen by slit lamp examination
    E.4Principal exclusion criteria
    •< 18 years of age
    •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
    •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive β HCG laboratory test
    •History of hypersensitivity to ranibizumab
    •Use of other investigational drugs within 30 days or 5 half-lives from Baseline, whichever is longer.
    •Use of any systemic anti-angiogenic drugs 3 months before inclusion
    •CNV secondary to PM, wAMD or PXE
    •ME secondary to DME or RVO
    •Posterior segment inflammation secondary to non infectious uveitis that might benefit from dexamethasone (Ozurdex®) according to investigator judgment
    •History of intraocular treatment with any anti-angiogenic drugs (including any anti-VEGF agents) or corticosteroids within 2 months before inclusion
    •Active or suspected ocular infection
    E.5 End points
    E.5.1Primary end point(s)
    •Adverse events, serious and non-serious, ocular and non-ocular
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 2 years
    E.5.2Secondary end point(s)
    •ranibizumab efficacy at 3 months as assessed by suitable endpoint for each disease category over all monthly post-baseline assessments from Month 1 to Month 3:
    oBCVA change for diseases affecting the macular area either through CNV or ME
    oChange of the extent of iris neovascularization using “Teich and Walsh grading system” using iris photography for NVG/RI
    •To describe 6, 12, 24 months ranibizumab efficacy as assessed by the suitable endpoint over all monthly post-baseline assessments from Month 1 to Month 6, 12, 24.
    •To analyze efficacy results taking into account patient profile, demographic characteristics, past and current medical history, prior treatment, and severity of disease.
    •To describe relevant anatomical parameters (retinal thickness, fluid leakage, …) change over time (Months 3, 6, 12, 24)
    •To describe patient management: yearly average number of ranibizumab injections, reasons for retreatment, use of other treatments and yearly average number of follow-up visits.

    oOccurrence of postoperative vitreous cavity hemorrhage for PDR/V
    E.5.2.1Timepoint(s) of evaluation of this end point
    at month 3, 6, 12, 24
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    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 concerned40
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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.1.3Elderly (>=65 years) Yes
    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 No
    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 state500
    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)
    None
    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 Decision2013-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-04-11
    P. End of Trial
    P.End of Trial StatusCompleted
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