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    Summary
    EudraCT Number:2019-001647-46
    Sponsor's Protocol Code Number:IIBSP-END-2018-96
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-11-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-001647-46
    A.3Full title of the trial
    Evaluation of the regenerative efficacy of Endoret® (PRGF-Plasm Rich in Growth Factors) on the ocular surface of glaucoma patients treated chronically with ocular hypotensive drugs
    Evaluación de la eficacia regenerativa de Endoret® (PRGF-Plasma Rico en Factores de Crecimiento) en la superficie ocular de pacientes glaucomatosos tratados de forma crónica con fármacos hipotensores oculares
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the regenerative efficacy of Endoret® (PRGF-Plasm Rich in Growth Factors) on the ocular surface of glaucoma patients treated chronically with ocular hypotensive drugs
    Estudio para evaluar la eficacia regenerativa de Endoret® (PRGF-Plasma Rico en Factores de Crecimiento) en la superficie ocular de pacientes con glaucoma tratados de forma crónica con fármacos hipotensores oculares
    A.4.1Sponsor's protocol code numberIIBSP-END-2018-96
    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 SponsorInstitut de Recerca H. de la Santa Creu i Sant Pau
    B.1.3.4CountrySpain
    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 supportInstitut de Recerca H. Santa Creu i Sant Pau
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537635
    B.5.5Fax number+34935537864
    B.5.6E-mailepenag@santpau.cat
    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 namePRP
    D.3.4Pharmaceutical form Eye drops
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPConjunctival use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlatelet Rich Plasma (PRP)
    D.3.9.3Other descriptive nameAUTOLOGOUS PLASMA
    D.3.9.4EV Substance CodeSUB117286
    D.3.10 Strength
    D.3.10.1Concentration unit Gtt drop(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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 Yes
    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
    Glaucoma
    Glaucoma
    E.1.1.1Medical condition in easily understood language
    Glaucoma
    Glaucoma
    E.1.1.2Therapeutic area Body processes [G] - Ocular Physiological Phenomena [G14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    General objective: To evaluate the changes produced, both clinically and biochemically and cytologically, by the topical treatment with PRGF on the ocular surface in patients with glaucoma chronically exposed to ocular hypotensive drugs.
    Main objective:To evaluate the changes in tear osmolarity produced after topical treatment with PRGF.
    Objetivo general: Evaluar los cambios producidos, tanto a nivel clínico como bioquímico y citológico, por el tratamiento tópico con PRGF sobre la superficie ocular en pacientes con glaucoma expuestos crónicamente a fármacos hipotensores oculares.
    Objetivo principal: Evaluar los cambios en la osmolaridad de la lágrima producidos tras el tratamiento tópico con PRGF.
    E.2.2Secondary objectives of the trial
    -To evaluate conjunctival clinical and cytological changes produced after topical treatment with PRGF
    -To evaluate the clinical and biochemical changes of the lacrimal film produced after the topical treatment of PRGF
    -To evaluate changes in symptomatology perceived by the patient after topical treatment with PRGF and changes in their quality of life.
    -To evaluate the safety of topical treatment with PGRF in patients with Glaucoma under treatment with ocular hypotensive drugs.
    -Evaluar los cambios clínicos y citológicos conjuntivales producidos tras el tratamiento tópico con PRGF
    -Evaluar los cambios clínicos y bioquímicos de la película lagrimal producidos tras el tratamiento tópico de PRGF
    -Evaluar los cambios en la sintomatología percibidos por el paciente tras el tratamiento tópico con PRGF y los cambios en su calidad de vida.
    -Evaluar la seguridad del tratamiento tópico con PGRF en pacientes con Glaucoma en tratamiento con fármacos hipotensores oculares.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients of legal age and diagnosed with glaucoma who are in treatment with at least two ocular hypotensive drugs (3 drops / day) without preservatives for at least the last two years and who consent to participate in the study.
    Pacientes mayores de edad y diagnosticados de glaucoma que se encuentren en tratamiento como mínimo con dos fármacos hipotensores oculares (3 gotas/día) sin conservantes durante, al menos, los dos últimos años y que den su consentimiento a participar en el estudio.
    E.4Principal exclusion criteria
    Pathology of the ocular surface other than toxicity by hypotensive drugs; previous ocular surface surgeries; treatments with topical blood products in the last 6 months, women of childbearing age with gestational desire, pregnant and lactating; serious adverse events during the study.
    Patología de superficie ocular diferente a toxicidad por fármacos hipotensores; cirugías de superficie ocular previas; tratamientos con hemoderivados tópicos en los últimos 6 meses, mujeres en edad fértil con deseo gestacional, gestantes y lactantes; acontecimientos adversos graves durante el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Tear osmolarity
    Osmolaridad de la lágrima
    E.5.1.1Timepoint(s) of evaluation of this end point
    Two and four months after the start of treatment
    A los dos y cuatro meses de iniciado el tratamiento
    E.5.2Secondary end point(s)
    -Symptoms of ocular surface pathology: It will be evaluated through the validated Ocular Surface Disease Index (OSDI ©) questionnaire.
    - Clinical signs of ocular surface pathology: corneo-conjunctival staining using fluorescein and evaluating according to Oxford scale, Lacrimal Tear Time (BUT) under slit lamp and fluorescein staining, measurement of lacrimal production by Schirmer test.
    - Cytological parameters of the conjunctiva, including the classification of Nelson and evaluating the presence and density of goblet cells.
    - Biochemical parameters of the tear film: The presence of proinflammatory cytokines in the tear (IFN gamma, TNF alpha, TGF beta, IL-2, IL-6, IL-17, IL-8, IL-13) will be analyzed.
    -Quality of life related to Vision: Validated Questionnaire National Eye Institute Visual Functioning Questionnaire-25 (VQ-25).
    -Adverse events.
    -Síntomas de patología de superficie ocular: Se evaluará mediante el cuestionario validado Ocular Surface Disease Index (OSDI©).
    -Signos clínicos de patología de superficie ocular: Tinción corneo-conjuntival utilizando fluoresceína y evaluando según escala de Oxford, Tiempo de Rotura Lagrimal (BUT) bajo lámpara de hendidura y tinción con fluoresceína, medición de la producción lagrimal mediante test de Schirmer.
    -Parámetros citológicos de la conjuntiva, incluyendo la clasificación de Nelson y evaluando la presencia y densidad de células caliciformes.
    -Parámetros bioquímicos de la película lagrimal: Se analizará la presencia de citoquinas proinflamatorias en la lágrima (IFN gamma,TNF alfa,TGF beta, IL-2, IL-6, IL-17, IL-8, IL-13).
    -Calidad de vida relacionada con la Visión: Cuestionario validado National Eye Institute Visual Functioning Questionnaire-25 (VQ-25).
    -Eventos adversos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Two and four months after the start of treatment
    A los dos y cuatro meses de iniciado el tratamiento
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.2.4Number of treatment arms in the trial1
    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 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
    Última visita del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    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: 30
    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 state30
    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 expected normal treatment of the studied condition
    El tratamiento habitual para la patología en estudio
    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 Decision2020-01-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-13
    P. End of Trial
    P.End of Trial StatusOngoing
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