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    Summary
    EudraCT Number:2017-003234-82
    Sponsor's Protocol Code Number:NTMT-03-A
    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:2018-10-03
    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 number2017-003234-82
    A.3Full title of the trial
    A Phase III Multicenter Randomized, Sham Controlled, Study to Determine the Safety and Efficacy of Renexus® in Macular Telangiectasia type 2
    Essai de phase III, multicentrique, randomisée, contrôlée en double aveugle, pour déterminer la sécurité et l’efficacité du Renexus® dans la Télangiectasie Maculaire de type 2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase III clinical trial to determine the safety and effectiveness of Renexus, an implant in the eye shown to reduce the rate of progression of Macular Telangiectasia type 2
    Essai clinique de phase III pour déterminer la sécurité et l'efficacité de Renexus, un implant oculaire réduisant le taux de progression de Maclan Telangiectasia type 2
    A.3.2Name or abbreviated title of the trial where available
    NTMT-03-A
    A.4.1Sponsor's protocol code numberNTMT-03-A
    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 SponsorNeurotech Pharmaceuticals
    B.1.3.4CountryUnited States
    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 supportNeurotech Pharmaceuticals Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNeurotech Pharmaceuticals
    B.5.2Functional name of contact pointJenni Bursell
    B.5.3 Address:
    B.5.3.1Street Address900 Highland Corporate Drive, Suite 101
    B.5.3.2Town/ cityCumberland, RI
    B.5.3.3Post code02864
    B.5.3.4CountryUnited States
    B.5.4Telephone number0014014952388
    B.5.5Fax number0014013333881
    B.5.6E-mailj.bursell@neurotechusa.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 Yes
    D.2.5.1Orphan drug designation numberEMA/OD/160/11
    D.3 Description of the IMP
    D.3.1Product nameRenexus®
    D.3.2Product code NT501.6A.02
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntraocular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCiliary Neurotrophic factor (CNTF)
    D.3.9.2Current sponsor codeNT501.6A.02
    D.3.10 Strength
    D.3.10.1Concentration unit ng nanogram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product Yes
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Yes
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberEMA/CAT/570019/2012
    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
    Macular Telangiectasia type 2
    Télangiectasie maculaire de type 2
    E.1.1.1Medical condition in easily understood language
    Macular telangiectasia (MacTel) is a disease affecting the macula, causing loss of central vision. MacTel develops when there are problems with the tiny blood vessels around the fovea.
    La télangiectasie maculaire est une maladie affectant la macula et entraînant une perte de vision centrale. Elle se développe en cas de problèmes avec les petits vaisseaux sanguins entourant la fovea.
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to investigate the effect of Renexus® on the mean change from baseline in the ellipsoid zone (area of IS/OS loss) as measured by SD-OCT in eyes with evidence of MacTel Type 2 through 24 months.
    L'objectif principal est d'étudier l'effet de Renexus® sur le changement moyen par rapport à la ligne de base dans la zone ellipsoïde (zone de perte IS / OS) mesurée par SD-OCT dans les yeux avec une preuve de MacTel Type 2 à 24 mois.
    E.2.2Secondary objectives of the trial
    The secondary objective of this study is to evaluate the safety of Renexus® in patients with MacTel Type 2.
    L'objectif secondaire de cette étude est d'évaluer la sécurité de Renexus® chez les patients atteints de MacTel Type 2.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To participate in this study, the potential participant and at least one of his or her eyes must meet all of the following criteria:

    1. Participant must have at least one study eye with a positive diagnosis of MacTel Type 2 with evidence of fluorescein leakage typical of MacTel or at least one of the other features including retinal opacification, crystalline deposits, right angle vessels, inner/outer lamellar cavities or hyperpigmentation not involving the center of the fovea, but no evidence of intraretinal/subretinal neovascularization and no evidence of retinal pigment epithelial hyperpigmentation.

    2. Participant must have an IS/OS PR break and en face ellipsoid zone (area of IS/OS loss) as measured by SD-OCT between 0.16 mm2 and 2.00 mm2.

    3. Participant's best corrected visual acuity is 54 letter score or better (20/80 or better) as measured by the ETDRS chart;

    4. Participant must have steady fixation in the foveal or parafoveal area and sufficiently clear media for good quality photographs;

    5. Participant must be greater than 21 years of age or less than 80 years of age

    6. Participant must be able to provide a written informed consent to participate in the study, in accordance with the ICH GCP guidelines, and local regulations, before initiating any study related procedures.
    Pour participer à cette étude, le participant potentiel et au moins un de ses yeux doivent répondre à tous les critères suivants:

    1. Le participant doit avoir au moins un œil d'étude avec un diagnostic positif de MacTel Type 2 avec une preuve de fuite de fluorescéine typique de MacTel ou au moins une des autres caractéristiques, y compris l'opacification rétinienne, les dépôts cristallins, les récipients à angle droit, les cavités lamellaires internes / externes ou une hyperpigmentation n'impliquant pas le centre de la fovea, mais aucune preuve de néovascularisation intrarélectrique / sous-rétinienne et aucune preuve d'hyperpigmentation épithéliale du pigment rétinien.

    2. Le participant doit disposer d'une zone de rupture et d'élimination de l'interface solaire / IS (zone de perte d'IS / OS) mesurée par SD-OCT entre 0,16 mm2 et 2,00 mm2.

    3. L'acuité visuelle la mieux corrigée du participant est un score de 54 lettres ou mieux (20/80 ou mieux), tel que mesuré par le tableau ETDRS;

    4. Le participant doit avoir une fixation stable dans la zone foveale ou parapheveale et des médias suffisamment clairs pour des photographies de bonne qualité;

    5. Le participant doit avoir plus de 21 ans ou moins de 80 ans

    6. Le participant doit être en mesure de fournir un consentement écrit et éclairé pour participer à l'étude, conformément aux lignes directrices de l'ICH GCP et aux règlements locaux, avant de lancer toute procédure relative à l'étude.
    E.4Principal exclusion criteria
    To participate in this study, the potential participant must not meet any of the following criteria. The ocular exclusion criteria are related to the study eye (unless indicated for either eye):

    1. Participant is medically unable to comply with study procedures or follow-up visits;

    2. Participant received intravitreal steroid therapy for non-neovascular MacTel within the last 3 months;

    3. Participant has ever received intravitreal anti-VEGF therapy for neovascular disease complicating MacTel in either eye;

    4. Participant has evidence of ocular disease other than MacTel that, in the judgment of the examining physician, may confound the diagnosis, procedures or outcome of the study (e.g., glaucoma, severe non-proliferative or proliferative diabetic retinopathy, uveitis, etc.);

    5. Participant has a chronic requirement (e.g., ≥ 4 weeks at a time) for ocular medications and/or has a diagnosed disease that, in the judgment of the examining physician, may be vision threatening or may affect the primary outcome (artificial tears are permitted);

    6. Participant has evidence of intra-retinal/sub-retinal neovascularization in either eye;

    7. Participant has evidence of central serous chorio-retinopathy (CSCR) in either eye;

    8. Participant has evidence of pathologic myopia in either eye;

    9. Participant has significant corneal or media opacities in either eye;

    10. Participant has had a vitrectomy, penetrating keratoplasty, trabeculectomy or trabeculoplasty

    11. Participant has any of the following lens opacities: cortical opacity > standard 3, posterior subcapsular opacity > standard 2, or a nuclear opacity > standard 3 as measured on the AREDS clinical lens grading system;

    12. Participant has undergone lens removal in the previous 3 months or YAG laser within 4 weeks;

    13. Participant was a study participant in any other clinical trial of an intervention (drug or device ) within the last 6 months;

    14. Participant is on chemotherapy;

    15.Participant is pregnant or breastfeeding;

    16.Participant has a history of malignancy that would compromise the 24-month study survival;

    17.Participant is on immunosuppressive therapy;

    18.Participant is considered immunodeficient or has a diagnosis of HIV;

    19.Participant with a history of ocular Herpes virus in either eye; or

    20.Participant has, in the opinion of the Investigator, any physical or mental condition that would increase the risk of participation in the study or may interfere with the study procedures, evaluations and outcome assessments.
    Pour participer à cette étude, le participant potentiel ne doit satisfaire à aucun des critères suivants. Les critères d'exclusion oculaire sont liés à l'œil de l'étude (sauf indication contraire pour l'un ou l'autre œil):

    1. Le participant n'est médicalement incapable de se conformer aux procédures d'étude ou aux visites de suivi;

    2. Le participant a reçu une thérapie par stéroïde intravitréel pour MacTel non-néovasculaire au cours des 3 derniers mois;

    3. Le participant a déjà reçu un traitement intravitréel anti-VEGF pour une maladie néovasculaire compliquant MacTel dans l'un ou l'autre œil;

    4. Le participant a une preuve d'une maladie oculaire autre que MacTel qui, selon le médecin examinateur, peut confondre le diagnostic, les procédures ou les résultats de l'étude (p. Ex. Glaucome, rétinopathie diabétique non proliférative sévère ou proliférative, uvéite, etc.). );

    5. Le participant a une exigence chronique (par exemple, ≥ 4 semaines à la fois) pour les médicaments oculaires et / ou a une maladie diagnostiquée qui, selon le médecin examinateur, peut être menaçant la vision ou affecter le résultat primaire (larmes artificielles sont autorisés);

    6. Le participant a une preuve de la néovascularisation intra-rétinienne / sous-rétinienne dans l'un ou l'autre œil;

    7. Le participant présente des signes de chorio-rétinopathie séreuse centrale (CSCR) dans les deux yeux;

    8. Le participant a des signes de myopie pathologique dans les deux yeux;

    9. Le participant a des opacities importantes de la cornée ou des médias dans les deux yeux;

    10. Le participant a eu une vitrectomie, une kératoplastie pénétrante, une trabéculectomie ou une trabécululope

    11. Le participant a l'une des opaciités de lentille suivantes: opacité corticale> norme 3, opacité sous-capsulaire postérieure> standard 2, ou une opacité nucléaire> norme 3 mesurée sur le système de calage clinique AREDS;

    12. Le participant a subi un retrait d'objectif au cours des 3 mois précédents ou un laser YAG dans les 4 semaines;

    13. Le participant a été participant à une étude dans tout autre essai clinique d'une intervention (médicament ou dispositif) au cours des 6 derniers mois;

    14. Le participant est en chimiothérapie;

    15. Le participant est enceinte ou allaite;

    16. Le participant a des antécédents de malignité qui compromettrait la survie à l'étude de 24 mois;

    17. Le participant est en traitement immunosuppresseur;

    18. Le participant est considéré comme immunodépendant ou a un diagnostic de VIH;

    19.Participant avec une histoire de virus de l'herpès oculaire dans l'un ou l'autre œil; ou

    20. Le demandeur a, de l'avis de l'enquêteur, une condition physique ou mentale qui augmenterait le risque de participation à l'étude ou pourrait interférer avec les procédures d'étude, les évaluations et les évaluations des résultats.
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome will be the mean change in the ellipsoid zone (area of IS/OS loss) from baseline through 24 months as measured by en face imaging by SD-OCT in the study eye.
    Le résultat principal sera le changement moyen dans la zone ellipsoïde (zone de perte d'IS / OS) de la ligne de base à 24 mois, mesurée par imagerie en face par SD-OCT dans l'œil d'étude.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, day 1, week 1 and 6, 12, 16, 20, and 24 months
    E.5.2Secondary end point(s)
    • Renexus® compared to sham relative to mean change in central macular thickness as measured by SD-OCT from baseline through 24 months
    Renexus® compared to sham relative proportion of eyes with > 35% increase in EZ break area from baseline at Month 24 only

    • Renexus ® compared to sham relative to mean change in aggregate sensitivity of microperimetry within the EZ line break area through 24 months
    Renexus® compared to sham relative to mean change in reading speed from baseline through 24 months

    • Renexus® compared to sham relative to mean change in the NEI-VFQ near activities subscale score from baseline through 24 months

    • Secondary safety endpoint: Persistent deterioration in visual acuity as evidenced by a loss of >15 letters using the ETDRS distance chart
    Renexus® comparé à l'aveugle par rapport à la variation moyenne de l'épaisseur maculaire centrale mesurée par SD-OCT de la ligne de base à 24 mois

    Renexus® comparé à l'aveugle par rapport à la proportion relative simulée des yeux avec une augmentation de 35% de la zone de rupture EZ à partir de la ligne de base au mois 24 seulement

    Renexus ® comparé à l'aveugle par rapport à la variation moyenne de la sensibilité agrégée de la microperimétrie dans la zone de rupture de la ligne EZ pendant 24 mois

    Renexus® comparé à l'aveugle par rapport à la variation moyenne de la vitesse de lecture de la ligne de base à 24 mois

    Renexus® comparé à l'aveugle par rapport à la variation moyenne dans le score de sous-échelle NEI-VFQ près des activités de base à 24 mois

    Point final de sécurité secondaire: détérioration persistante de l'acuité visuelle, comme en témoignent une perte de> 15 lettres en utilisant le diagramme de distance ETDRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    Baseline, day 1, week 1 and 6, 12, 16, 20, and 24 months
    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 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 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
    Sham implant
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    United States
    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 years2
    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 years2
    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.1.2.1Number of subjects for this age range: 112
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 112
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 75
    F.4.2.2In the whole clinical trial 112
    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)
    Subject returns to normal care provided by their physician
    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 Decision2018-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-08-09
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