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    Summary
    EudraCT Number:2015-002415-15
    Sponsor's Protocol Code Number:TG-MV-015
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-01-21
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2015-002415-15
    A.3Full title of the trial
    A PHASE 2, RANDOMISED, DOUBLE-MASKED, SHAM-CONTROLLED, MULTI-CENTRE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT (PVD) IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY (NPDR) (CIRCLE)
    Studio di fase 2 multicentrico, randomizzato, a doppio mascheramento, controllato con simulazione per la valutazione della sicurezza e dell¿efficacia di ocriplasmina nell¿indurre il distacco posteriore totale del vitreo (PVD) in soggetti con retinopatia diabetica non proliferativa (NPDR)( Studio CIRCLE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCRIPLASMIN IN INDUCING TOTAL POSTERIOR VITREOUS DETACHMENT IN SUBJECTS WITH NON-PROLIFERATIVE DIABETIC RETINOPATHY
    Uno studio per valutare l'efficacia e la sicurezza di ocriplasmina nell¿indurre il distacco posteriore totale del vitreo in soggetti con retinopatia diabetica non proliferativa
    A.3.2Name or abbreviated title of the trial where available
    CIRCLE
    CIRCLE
    A.4.1Sponsor's protocol code numberTG-MV-015
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02681809
    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 SponsorOXURION NV
    B.1.3.4CountryBelgium
    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 supportThromboGenics NV
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThromboGenics NV
    B.5.2Functional name of contact pointGlobal Clinical Development
    B.5.3 Address:
    B.5.3.1Street AddressGaston Geenslaan 1
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post codeB-3001
    B.5.3.4CountryBelgium
    B.5.4Telephone number32 (0)16 751 310
    B.5.5Fax number32 (0)16 751 311
    B.5.6E-mailinfo@thrombogenics.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 JETREA 0.5 mg/0.2 ml concentrato per soluzione iniettabile EU/1/13/819/001
    D.2.1.1.2Name of the Marketing Authorisation holderThromboGenics NV
    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.3.4Pharmaceutical form Concentrate for 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 INNOCRIPLASMINA
    D.3.9.1CAS number 1048016-09-6
    D.3.9.2Current sponsor code-
    D.3.9.4EV Substance CodeSUB33018
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    Moderate to very severe non-proliferative diabetic retinopathy (NPDR)
    Retinopatia diabetica non proliferativa da moderata a molto grave (NPDR)
    E.1.1.1Medical condition in easily understood language
    Eye problems caused by diabetes (called 'diabetic retinopathy')
    Problemi agli occhi causati da diabete ( denominata " retinopatia diabetica")
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10054109
    E.1.2Term Non-proliferative diabetic retinopathy
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe NPDR, to induce total PVD in order to reduce the risk of disease progression to PDR
    Valutare la sicurezza e l¿efficacia di un massimo di 3 iniezioni intravitreali di ocriplasmina (0,0625 mg o 0,125 mg), in soggetti con retinopatia diabetica non proliferativa (NPDR) da moderata a molto grave, nell¿indurre il distacco posteriore totale del vitreo (PVD) al fine di ridurre il rischio di progressione in retinopatia diabetica proliferativa (PDR)
    E.2.2Secondary objectives of the trial
    Not applicable
    Non applicabile
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Male or female aged 18 years or older
    - BCVA of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
    - BCVA of 20 letters read or greater (Snellen equivalent of 20/400 or better) in the fellow eye
    - Clear ocular media for adequate fundus imaging in the study eye
    - HbA1c = 12%, as assessed by the central laboratory
    - Moderate to very severe NPDR as per ETDRS Severity Scale (Levels 43A-53E), based on 7 standard field colour fundus photograph, as assessed by the central reading centre (CRC)
    - No evidence of total PVD in the study eye, based on both B-scan ultrasound and SD-OCT, as assessed by the B-scan expert reader and the CRC, respectively
    - Written informed consent obtained from the subject prior to screening procedures
    - Central subfield thickness ( CST) of =340µm on Spectralis SD-OCT or =320µm on non-Spectralis SD-OCT in the study eye, as assessed by the CRC with or without mild CI-DME
    •Soggetti di sesso maschile o femminile di età =18 anni
    •Migliore acuità visiva corretta (BCVA) =65 lettere (equivalente di Snellen =20/50) nell’occhio in studio
    •BCVA =20 lettere (equivalente di Snellen =20/400) nell’occhio non in studio
    •Bulbo oculare limpido per l’esame del fundus nell’occhio in studio
    •HbA1c =12%, secondo la valutazione del laboratorio centrale
    •NPDR da moderata a molto grave secondo la scala di gravità ETDRS (livelli 43A-53E), sulla base della fotografia del fundus a colori in stereoscopia a 7 campi standard valutata dal CRC
    •Assenza di evidenze di PVD totale nell’occhio in studio sulla base dell’ecografia B-Scan e della SD-OCT valutate rispettivamente dall’esperto refertatore e dal CRC
    •Acquisizione del consenso informato scritto dal soggetto prima delle procedure di screening
    •Spessore del sottocampo centrale ( CST) di =340µm su SD-OCT o =320µm su SD-OCT non spettrale nell’occhio in studio, come valutato dal CRC, con o senza edema maculare diabetico con lieve coinvolgimento del centro (Centre-Involved DME, CI-DME)
    E.4Principal exclusion criteria
    - History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR (e.g. exudative AMD, retinal vein occlusion [branch or central vein], uveitis, angioid streaks, histoplasmosis, toxoplasmosis, rhegmatogenous retinal detachment, retinal tear, fibrovascular proliferation, lattice degeneration, macular hole, ocular tumours)
    - Significant ocular trauma in the study eye within 6 months prior to screening (including corneo scleral laceration, lens subluxation, cryo-retinopexy)
    - Corneal, lenticular, or ocular media abnormalities in the study eye that preclude observation with the slit lamp or accurate readings with a tonometer
    - Presence of epiretinal membrane in the study eye, based on SD-OCT, as assessed by the CRC
    - Presence of foveal ischemia in the study eye, based on fluorescein angiograph, as assessed by the CRC
    - Presence of pre-retinal or vitreous haemorrhage in the study eye
    - Presence of iris or angle neovascularisation in the study eye
    - Any active ocular / intraocular infection or inflammation in either eye (e.g. blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis, uveitis)
    - Open angle glaucoma or uncontrolled glaucoma in the study eye (uncontrolled glaucoma is defined as intraocular pressure [IOP] = 26mmHg despite treatment with anti-glaucoma medication)
    - More than 8D high myopia in the study eye
    - Aphakic study eye
    - Previous treatments / procedures in the stydy eye as follows: vitrectomy, PRP and Steroid implants [any time] // Intraocular surgery and Intravitreal and peri-ocular steroids [4 months] // Focal / grid laser photocoagulation and Intravitreal anti-VEGF [1 month] // Topical ocular steroids [1 month] [excluded period period to randomisation]
    - Uncontrolled hypertension in the opinion of the Investigator (e.g. systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg for at least 30 days prior to screening despite antihypertensive treatment, or any finding in the Investigator’s opinion suggesting hypertensive retinopathy)
    - Pseudoexfoliation, Marfan’s syndrome, phacodonesis or any other finding in the Investigator’s opinion suggesting lens / zonular instability
    - Current use of or possible need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine / hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol
    - Known hypersensitivity to ocriplasmin, its excipients or any of the medications that will be used for study procedures (e.g. fluorescein, antibiotics, anaesthetic eye drops, eye drops for pupil dilation)
    - Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception (where 1 method is barrier at the minimum)
    - Previous ocriplasmin injection in the study eye
    - History and / or current evidence of a systemic medical condition or any other reason that may, in the Investigator’s opinion, preclude adherence to the scheduled study visits / assessments and safe participation in the study
    - Concurrent participation in another clinical study, at any time during the entire study period, in which the subject has been or will be exposed to an investigational or a non investigational product (pharmaceutical product or device)
    - Use of any investigational, non-registered or off-label product within 30 days prior to screening, or planned use during the entire study period
    •Disturbo oculare, pregresso o corrente, nell’occhio in studio che può interferire con la valutazione della progressione in PDR (p. es. degenerazione maculare senile [AMD] essudativa, occlusione venosa retinica [ramo o vena centrale], uveite, strie angioidi, istoplasmosi, toxoplasmosi, distacco regmatogeno della retina, lacerazione della retina, proliferazione fibrovascolare, degenerazione a lattice, foro maculare, tumori oculari)
    •Trauma oculare significativo nell’occhio in studio nei 6 mesi precedenti lo screening (incluse lacerazione corneo-sclerale, sublussazione del cristallino, crioretinopessia)
    •Anomalie a carico della cornea, del cristallino o del bulbo oculare nell’occhio in studio che precludono l’osservazione con la lampada a fessura o misurazioni accurate alla tonometria
    •Presenza di membrana epiretinica nell’occhio in studio, come risulta dalla SD-OCT valutata dal CRC
    •Presenza di ischemia foveale nell’occhio in studio, come risulta dalla SD-OCT valutata dal CRC
    •Presenza di emorragia preretinica o vitrea nell’occhio in studio
    •Presenza di neovascolarizzazione dell’iride o dell’angolo nell’occhio in studio
    •Eventuali infezioni o infiammazioni oculari/intraoculari attive in uno degli occhi (p. es. blefarite, congiuntivite infettiva, cheratite, sclerite, endoftalmite, uveite)
    •Glaucoma ad angolo aperto o glaucoma non controllato nell’occhio in studio (il glaucoma non controllato è definito come pressione intraoculare [IOP] =26mmHg malgrado il trattamento con un farmaco specifico contro il glaucoma)
    •Miopia grave (>8D) nell’occhio in studio
    • Occhio in studio afatico
    •Precedenti Trattamenti/Procedura nell’occhio in studio
    Vitrectomia (Qualsiasi momento), Fotocoagulazione panretinica (PRP) (Qualsiasi momento) Intervento di chirurgia intraoculare (4 mesi); Fotocoagulazione laser focale/a griglia (3 mesi); Anti-VEGF per via intravitreale (1 mese) ; Steroidi oculari topici (1 mese)
    Steroidi per via intravitreale e perioculare (4 mesi)
    Impianti steroidei (Qualsiasi momento);
    • Ipertensione non controllata nell’opinione dello sperimentatore (p. es. pressione arteriosa sistolica >160mmHg o diastolica >100mmHg da almeno 30 giorni prima dello screening malgrado il trattamento con antipertensivi, o eventuale reperto che nell’opinione dello sperimentatore è indicativo di retinopatia ipertensiva)
    •Pseudoesfoliazione, sindrome di Marfan, facodonesi o qualsiasi altro reperto che nell’opinione dello sperimentatore è indicativo di instabilità zonulare / del cristallino
    •Uso corrente o possibile necessità di farmaci sistemici che hanno un effetto tossico noto sul cristallino, sulla retina o sul nervo ottico, inclusi deferoxamina, clorochina/idrossiclorochina (Plaquenil), tamoxifene, fenotiazine ed etambutolo
    •Ipersensibilità nota a ocriplasmina, ai suoi eccipienti o a qualsiasi farmaco usato per le procedure di studio (p. es. fluoresceina, antibiotici, colliri anestetici, colliri per la dilatazione della pupilla)
    •Donne in stato di gravidanza o allattamento o in età fertile che non usano una forma adeguata di contraccezione o uomini in grado di procreare che non usano metodi contraccettivi (laddove 1 metodo è la barriera minima)
    •Precedente iniezione di ocriplasmina nell’occhio in studio
    •Storia o evidenze correnti di una patologia medica sistemica o qualsiasi altra ragione che, nell’opinione dello sperimentatore, potrebbe precludere l’aderenza alle visite in studio/valutazioni programmate e la partecipazione allo studio senza rischi per la sicurezza
    •Partecipazione concomitante a un altro studio clinico, in qualsiasi momento durante l’intero periodo di studio, nell’ambito del quale il soggetto è stato o sarà esposto a un prodotto sperimentale o non sperimentale (prodotto farmaceutico o dispositivo)
    •Uso di un prodotto sperimentale, non approvato o off-label nei 30 giorni precedenti lo screening o uso previsto durante l’intero periodo di studio
    E.5 End points
    E.5.1Primary end point(s)
    Total PVD by the Month 3 visit, confirmed on both B-scan ultrasound and SD-OCT (6mm), as assessed by the masked B-scan expert reader and the masked CRC, respectively
    PVD totale entro la visita del Mese 3 confermato sia all’ecografia B-Scan che alla SD-OCT (6 mm), valutate rispettivamente dall’esperto refertatore e dal CRC, entrambi operanti in cieco
    E.5.1.1Timepoint(s) of evaluation of this end point
    Month 3 visit
    Visita al mese 3
    E.5.2Secondary end point(s)
    Principal safety endpoints:
    -ocular TEAEs in the study eye
    Safety will ve further assessed through reported TEAEs, full ophthalmic eamination, BCVA assessment, assessment of colour vision ( subset), SD-OCT, ffERG ( subset) and assessment of immunogenicity.
    Principali endpoints di sicurezza: TEAE oculari nell¿occhio in studio.
    La sicurezza sar¿ ulteriormente valutata sulla base dei TEAE segnalati, dell¿esame oftalmologico completo, della valutazione della BCVA, della valutazione della visione a colori (in sottogruppo), della SD-OCT, dell¿esame ffERG (in sottogruppo) e della valutazione dell¿immunogenicit¿
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the time of providing consent until the end of the study
    Dalla firma del consneso sino alla fine dello studio.
    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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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
    Flaconcini di trattamento sham vuoti, nessuna penetrazione del globo, lo sperimentatore imiter¿ la p
    Sham empty vials, no penetration of the globe, Investigator to mimic the test injection procedure
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Canada
    Israel
    United States
    Belgium
    Czechia
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Spain
    United Kingdom
    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
    The end of the trial is defined as the last visit of the last subject (LVLS) unless the data monitoring committee (DMC) recommends premature termination of the trial as a result of safety concerns.
    La fine dello studio ¿ definita come l'ultima visita dell'ultimo soggetto (LPLV) a meno che il comitato di monitoraggio dei dati (DMC) raccomandi interruzione prematura dello studio a causa di problemi di sicurezza.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days21
    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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 65
    F.4.2.2In the whole clinical trial 115
    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)
    Not applicable
    Non Applicabile
    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 Decision2016-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-01-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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