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    Summary
    EudraCT Number:2016-003329-40
    Sponsor's Protocol Code Number:15-API-01
    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:2017-01-10
    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 number2016-003329-40
    A.3Full title of the trial
    Neovascular glaucoma prevention by intravitreal injections of anti-VEGF in patients treated by protontherapy in case of large choroid melanoma
    Prévention du glaucome néovasculaire par injections intravitréennes d’anti-VEGF chez les patients traités par protonthérapie dans le cadre d’un mélanome choroïdien de grande taille
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Neovascular glaucoma prevention by intravitreal injections of anti-VEGF in patients treated by protontherapy in case of large choroidal melanoma
    Prévention du glaucome néovasculaire par injections intravitréennes d’anti-VEGF chez les patients traités par protonthérapie dans le cadre d’un mélanome choroïdien de grande taille
    A.4.1Sponsor's protocol code number15-API-01
    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 SponsorCHU de Nice
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMinistère de la Santé
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU de Nice
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address4 avenue Reine Victoria
    B.5.3.2Town/ cityNice
    B.5.3.3Post code06003
    B.5.3.4CountryFrance
    B.5.6E-maildrc@chu-nice.fr
    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 Eylea 40 mg/ml, solution injectable en seringue préremplie
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameAflibercept
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.11 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 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
    E.1.1.1Medical condition in easily understood language
    Patient with large choroid melanoma 7 mm thick and / or more than 15 mm of basal diameter treated by proton therapy
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.1
    E.1.2Level PT
    E.1.2Classification code 10008773
    E.1.2Term Choroid melanoma
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Compare neovascular glaucoma rate 5 years after proton therapy, in patients large with choroid melanoma, between a group of patients treated preventively by intravitreal anti-VEGF versus a second group of patients receiving a false injection.
    E.2.2Secondary objectives of the trial
    - Compare neovascular glaucoma rates at 2 years after proton therapy.
    - Comparison of the rate of occurrence of radiation-induced complications: retinopathy, maculopathy, and radiation-induced neuropathies, and exudative retinal detachment.
    - Comparison of enucleation rate
    - Description and comparison of changes in visual acuity between the two groups of patients
    - Description and comparison of the development of the local tumor regression after proton therapy according to groups
    - Comparison of local recurrence at 2 and 5 years.
    - Description of changes in intraocular secretion of pro-angiogenic cytokines.
    - Analysis of the metastasis-free survival, overall and specific at 2 and 5 years.
    - Comparison of the evolution of quality of life
    - Comparison of the incidence of local and general adverse events
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age ≥ 18 years
    - Choroid melanoma more than 7 mm thick and / or over basal diameter of 15mm treated by proton therapy
    E.4Principal exclusion criteria
    - Iris melanoma
    - Melanoma immediately metastatic
    - Pregnant or breastfeeding women
    - Known hypersensitivity to aflibercept (anti-VEGF selected)
    E.5 End points
    E.5.1Primary end point(s)
    Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 5 years
    E.5.2Secondary end point(s)
    - Compare neovascular glaucoma rates at 2 years after proton therapy.
    - Comparison of the rate of occurrence of radiation-induced complications: retinopathy, maculopathy, and radiation-induced neuropathies, and exudative retinal detachment.
    - Comparison of enucleation rate
    - Description and comparison of changes in visual acuity between the two groups of patients
    - Description and comparison of the development of the local tumor regression after proton therapy according to groups
    - Comparison of local recurrence at 2 and 5 years.
    - Description of changes in intraocular secretion of pro-angiogenic cytokines.
    - Analysis of the metastasis-free survival, overall and specific at 2 and 5 years.
    - Comparison of the evolution of quality of life
    - Comparison of the incidence of local and general adverse events
    E.5.2.1Timepoint(s) of evaluation of this end point
    - At 2 years after proton therapy.
    - At 5 years
    - During 5 years
    - During 5 years
    - During 5 years
    - At 2 and 5 years.
    - At 5 years
    - At 2 and 5 years.
    - During 5 years
    - During 5 years
    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 No
    E.6.5Efficacy No
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    simulation d'injection
    false injection
    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 concerned2
    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 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 years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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: 56
    F.1.3Elderly (>=65 years) No
    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 No
    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 state56
    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 Decision2016-11-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-19
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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