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    Summary
    EudraCT Number:2018-003042-16
    Sponsor's Protocol Code Number:IIBSP-PTE-2018-35
    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:2018-10-09
    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 number2018-003042-16
    A.3Full title of the trial
    Randomized clinical trial to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft in terms of recurrence during the first year after surgery
    Ensayo clínico aleatorizado para evaluar la eficacia del injerto de membrana de fibrina con colirio concentrado en factores de crecimiento autólogo en la cirugía de pterigio primario comparándola con el injerto de membrana amniótica en términos de recidiva durante el primer año después de la cirugía
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy of fibrin membrane graft with eye drops concentrated in autologous growth factors in primary pterygium surgery comparing it with amniotic membrane graft
    Estudio para evaluar la eficacia del injerto de membrana de fibrina con colirio concentrado en factores de crecimiento autólogo en la cirugía de pterigio primario comparándola con el injerto de membrana amniótica
    A.4.1Sponsor's protocol code numberIIBSP-PTE-2018-35
    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 Antoni Maria Claret 167
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537635
    B.5.5Fax number+34935537812
    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 number3
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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 Amniotic membrane
    D.2.1.1.2Name of the Marketing Authorisation holderBanco de Sangre y Tejidos
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameAmniotic membrane
    D.3.4Pharmaceutical form Implantation matrix
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntralesional use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAmniotic membrane
    D.3.9.3Other descriptive nameAmniotic membrane
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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
    Pterigyum
    Pterigion
    E.1.1.1Medical condition in easily understood language
    Pterigyum
    Pterigion
    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
    To evaluate the efficacy, through the rate of recurrence during the first postoperative year, of the fibrin membrane graft and concentrated eye drops in autologous growth factors in primary pterygium surgery, comparing it with the amniotic membrane graft.
    Evaluar la eficacia, a través de la tasa de recidiva durante el primer año postoperatorio, del injerto de membrana de fibrina y colirio de concentrado en factores de crecimiento autólogos en la cirugía de pterigio primario, comparándola con el injerto de membrana amniótica.
    E.2.2Secondary objectives of the trial
    - Evaluate and compare the epithelization time after surgery in both techniques
    - Evaluate tissue healing in both techniques.
    - Evaluate the safety and surgical and post-surgical complications of both techniques: scleritis, persistent epithelial defect, graft retraction, graft loss, intraocular hypertension secondary to corticosteroids.
    - Evaluar y comparar el tiempo de epitelización tras la cirugía en ambas técnicas
    - Evaluar la cicatrización tisular en ambas técnicas.
    - Evaluar la seguridad y las complicaciones quirúrgicas y post quirúrgicas de ambas técnicas: escleritis, defecto epitelial persistente, retracción del injerto, pérdida del injerto, hipertensión intraocular secundaria a los corticoesteroides.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Uni or bilateral primary pterygium with growth of fibrovascular proliferation.
    - Patients between 20 and 60 years old
    - Corneal invasion with risk of visual affectation and / or eye discomfort due to pterygium.
    - Pterigio primario uni o bilateral con crecimiento de la proliferación fibrovascular.
    - Pacientes con edad entre 20 y 60 años
    - Invasión corneal con riesgo de afectación visual y/o molestias oculares debidas al pterigio.
    E.4Principal exclusion criteria
    - Prior pterygium surgery (recurrent pterygium)
    - Pseudopterigio
    - Use of topical or systemic immunosuppressive or immunomodulatory treatment
    - Use of chronic topical ocular treatment except artificial tears
    - Antecedents of palpebral disease or ocular surface
    - Cirugía previa de pterigio (pterigio recidivante)
    - Pseudopterigio
    - Uso de tratamiento inmunosupresor o inmunomodulador tópico o sistémico
    - Uso de tratamiento ocular tópico crónico excepto las lágrimas artificiales
    - Antecedentes de enfermedad palpebral o de la superficie ocular
    E.5 End points
    E.5.1Primary end point(s)
    Recurrence rate. Defined as the number of recurrences per technique divided between surgeries performed with an amniotic membrane implant and those using a fibrin graft rich in growth factors. Understanding as recurrence the appearance of fibrovascular proliferation invading the corneal limbus and the cornea.
    Tasa de recidivas. Definida como el número de recidivas por técnica dividida entre las cirugías realizadas con implante de membrana amniótica y las que se usa el injerto de fibrina rica en factores de crecimiento. Entendiendo como recidiva la aparición de proliferación fibrovascular invadiendo el limbo corneal y la córnea.
    E.5.1.1Timepoint(s) of evaluation of this end point
    It will be evaluated at month, two months, three months, six months and the year after the intervention.
    Se evaluará al mes, dos meses, tres meses, seis meses y al año tras la intervención.
    E.5.2Secondary end point(s)
    - Epithelization time in both techniques. Defined as the number of days it takes to grow the epithelial cells on the amniotic membrane or fibrin graft by measuring it with fluorescein staining (epithelialization corresponds to negative staining). While there is an epithelial defect, the patient will be visited every 2 days.
    - Correct tissue healing (YES / NO). Defined as the epithelization and healing of the conjunctiva with appearance similar to the healthy conjunctiva, without granulomas, without lines of fibrosis, without vascular proliferation.
    - Security. Defined as the number of surgical complications in both techniques during the first three months of follow-up. The following are mainly registered: scleritis, persistent epithelial defect, graft retraction, graft loss, granuloma, intraocular hypertension secondary to corticosteroids.
    - Tiempo de epitelización en ambas técnicas. Definido como el número de días que tarda en crecer las células epiteliales sobre el injerto de membrana amniótica o de fibrina midiéndolo con la tinción de fluoresceína (epitelización corresponde a tinción negativa). Mientras exista defecto epitelial el paciente se visitará cada 2 días.
    - Cicatrización tisular correcta (SI/NO). Definida como la epitelización y cicatrización de la conjuntiva con aspecto similar a la conjuntiva sana, sin granulomas, sin líneas de fibrosis, sin proliferación vascular.
    - Seguridad. Definida como el número de complicaciones quirúrgicas en ambas técnicas durante los primeros tres meses de seguimiento. Se registrarán principalmente las siguientes: escleritis, defecto epitelial persistente, retracción del injerto, pérdida del injerto, granuloma, hipertensión intraocular secundaria a los corticoesteroides.
    E.5.2.1Timepoint(s) of evaluation of this end point
    It will be evaluated at month, two months, three months, six months and the year after the intervention.
    Se evaluará al mes, dos meses, tres meses, seis meses y al año tras la intervención.
    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 Yes
    E.8.1.1Randomised Yes
    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 Yes
    E.8.2.3.1Comparator description
    Membrana amniótica
    Amniotic membrane
    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 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 years2
    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: 110
    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 state110
    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 Decision2019-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-16
    P. End of Trial
    P.End of Trial StatusOngoing
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