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    Summary
    EudraCT Number:2018-003597-26
    Sponsor's Protocol Code Number:1698-302-007
    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:2019-11-18
    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 number2018-003597-26
    A.3Full title of the trial
    An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in
    Patients with Open Angle Glaucoma or Ocular Hypertension
    Una extensión del ensayo para evaluar la seguridad y la eficacia a largo plazo del Bimatoprost SR en pacientes con glaucoma de ángulo abierto o hipertensión ocular
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in
    Patients with Open Angle Glaucoma or Ocular Hypertension
    Una extensión del ensayo para evaluar la seguridad y la eficacia a largo plazo del Bimatoprost SR en pacientes con glaucoma de ángulo abierto o hipertensión ocular
    A.3.2Name or abbreviated title of the trial where available
    Long-term Safety and Efficacy of Bimatoprost SR
    Seguridad y la eficacia a largo plazo del Bimatoprost SR
    A.4.1Sponsor's protocol code number1698-302-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03891446
    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 SponsorAllergan Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportAllergan LLC
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAllergan Ltd.
    B.5.2Functional name of contact pointCTRG
    B.5.3 Address:
    B.5.3.1Street Address1st Floor, Marlow, International Parkway
    B.5.3.2Town/ cityMarlow, Buckinghamshire
    B.5.3.3Post codeSL7 1YL
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailml-ctrg@allergan.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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameBimatoprost SR
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracameral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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.IMP: 2
    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 nameBimatoprost SR
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntracameral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNBIMATOPROST
    D.3.9.1CAS number 155206-00-1
    D.3.9.2Current sponsor codeAGN-192024
    D.3.9.4EV Substance CodeSUB12470MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    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) 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
    Open-angle Glaucoma and Ocular Hypertension
    Glaucoma de ángulo abierto o hipertensión ocular
    E.1.1.1Medical condition in easily understood language
    Open-angle Glaucoma and Ocular Hypertension
    Glaucoma de ángulo abierto o hipertensión ocular
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10030856
    E.1.2Term Open-angle glaucoma
    E.1.2System Organ Class 10015919 - Eye disorders
    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 safety of Bimatoprost SR in patients
    with OAG or OHT
    • To evaluate the duration of the IOP-lowering effect
    of Bimatoprost SR in patients with OAG or OHT
    • Evaluar la seguridad de Bimatoprost SR en pacientes con HTO o GAA.
    •Evaluar la duración del efecto de reducción de la PIO de Bimatoprost SR en pacientes con HTO o GAA.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent and authorization for use and release of personal health information are obtained in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU) sites])
    2. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
    3. Negative pregnancy test at Screening/Enrollment for females of childbearing potential (as defined in Appendix 6)
    4. Patients who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and who were:
    a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter) in the eye that received Bimatoprost SR, OR
    b. Rescued in the eye that received Bimatoprost SR and require additional safety follow-up for that eye based on the investigator’s discretion, OR
    c. Rescued in the eye that received Bimatoprost SR and require no additional safety follow-up but have clinically significant implant remnants remaining based on the investigator’s judgment
    1. El consentimiento informado por escrito y la autorización para el uso y divulgación de información personal de salud se obtienen de acuerdo con los requisitos de privacidad locales y del país correspondientes, según corresponda (por ejemplo, Autorización por escrito para el uso y divulgación de información de estudios de investigación y salud [sitios de EE. UU.] y Consentimiento por escrito de protección de datos (sitios de la UE)]
    2. El paciente tiene la capacidad de entender y estar dispuesto a seguir las instrucciones del estudio y es probable que complete todas las visitas y procedimientos requeridos
    3. Prueba de embarazo negativa en la selección / inclusión para mujeres en edad fértil (según se define en el Apéndice 6)
    4. Pacientes que completaron 1 de los 4 estudios de Bimatoprost SR Fase 3 (192024-091, -092, -093 o -095) y que fueron:
    a. No rescatado (se refiere a haber recibido medicamentos para bajar la PIO no estudiados [s] o procedimiento [s] o ambos, en adelante) en el ojo que recibió Bimatoprost SR, O
    b. Rescatado en el ojo que recibió Bimatoprost SR y requiere un seguimiento de seguridad adicional para ese ojo, según la discreción del investigador, O
    c. Rescatado en el ojo que recibió Bimatoprost SR y no requiere un seguimiento de seguridad adicional, pero aún quedan remanentes de implantes clínicamente significativos según el criterio del investigador
    E.4Principal exclusion criteria
    1. Patients who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092
    2. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study (see Appendix 6)
    3. Concurrent or anticipated enrollment in another investigational drug or device study during the present study
    4. Any condition which would preclude the patient’s ability to comply with study requirements, including completion of the study
    5. Patients who have a condition or are in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient’s participation in the study
    1. Pacientes que fueron asignados al azar para recibir gotas de timolol en el ojo del estudio (grupo de control) durante los Estudios de Bimatoprost de Fase 3 192024-091 y -092
    2. Pacientes de sexo femenino que están embarazadas, amamantando o planeando un embarazo, o que están en edad fértil y no usan un método anticonceptivo confiable durante el estudio (ver Apéndice 6)
    3. Inclusión simultánea o anticipada en otro estudio de investigación de medicamentos o dispositivos durante el presente estudio
    4. Cualquier condición que impida la capacidad del paciente para cumplir con los requisitos del estudio, incluida la finalización del estudio.
    5. Los pacientes que tienen una enfermedad o se encuentran en una situación que, en opinión del investigador, puede poner al paciente en un riesgo significativo, puede confundir los resultados del estudio o puede interferir significativamente con la participación del paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    • AEs, visual field, visual acuity, macroscopic conjunctival hyperemia, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments
    (including optic disc assessment), contact ultrasound pachymetry, gonioscopy (implant assessment), and specular microscopy
    • Key variable: time to first rescue treatment or Bimatoprost SR PRN retreatment Additional variables: time to first meeting the Bimatoprost SR PRN retreatment criteria in the study eye, time to second meeting the PRN retreatment criteria in study eye after the first PRN retreatment, time to first decision to administer rescue treatment in the SLT-treated eye for patients from Study 192024-093 or -095, number of PRN administrations required in the Bimatoprost SR treated eye in patients eligible for PRN retreatment to maintain effective IOP lowering (in the opinion of the investigator) compared with the SLT-treated eye, and study eye IOP
    • AA, campo visual, agudeza visual, hiperemia conjuntival macroscópica, valoraciones biomicroscópicas con lámpara de hendidura, exámenes oftalmoscópicos con la pupila dilatada (incluida evaluación del disco óptico) paquimetría ultrasónica de contacto, gonioscopia (evaluación de implantes) y microscopia especular
    • Variables clave: el tiempo que transcurre hasta la administración del primer tratamiento de rescate o la repetición del tratamiento PRN con Bimatoprost SR.
    Variables adicionales: el tiempo que transcurre hasta cumplir con los criterios de repetición del tratamiento PRN con Bimatoprost SR en el ojo del estudio; el tiempo que transcurre hasta cumplir por segunda vez los criterios de repetición del tratamiento PRN en el ojo del estudio, el tiempo que transcurre hasta decidir por primera vez administrar el tratamiento de rescate en el ojo tratado con una TSL en los pacientes del estudio 192024-093 o -095, y el número de administraciones PRN necesarias en el ojo tratado con Bimatoprost SR en los pacientes elegibles para una repetición del tratamiento PRN para lograr una reducción efectiva de la PIO (en opinión del investigador) en comparación con el ojo tratado con una TSL, y la presión PIO en el ojo del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    throughout the study
    a lo largo del estudio
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 Yes
    E.6.13.1Other scope of the trial description
    Gonioscopic Photography, Anterior Segment Imaging, Ocular Surface Photography, Implant Administration (and/or Removal) Video Recording
    Fotografía gonioscópica, Imagen del segmento anterior, Fotografía de superficie ocular, Administración de implantes (y / o extracción) Grabación de video
    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 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 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA26
    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
    Austria
    Belgium
    Czech Republic
    Denmark
    Egypt
    France
    Germany
    Israel
    Italy
    Poland
    Russian Federation
    South Africa
    Spain
    Turkey
    United Kingdom
    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 paciente
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 600
    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)
    Consenting patients will be allowed to continue study visits after Month 24 until the last visit of the last enrolled patient (LPLV, Month 24 or early exit), if the study eye did not receive rescue treatment during the lead-in Phase 3 study and during the first 24 months of the current study (Table 1-4). Depending on the time of enrollment, the overall study duration may vary for these study patients.
    A los pacientes que otorguen su consentimiento se les permitirá proseguir con las visitas del estudio después del mes 24 hasta que se efectúe la última visita del último paciente incluido en el estudio (UVUP, mes 24 o abandono prematuro), si el ojo del estudio no recibió tratamiento de rescate durante el estudio inicial de fase III ni durante los primeros 24 meses del estudio actual. La duración total del estudio para estos pacientes puede variar en función del momento de inclusión.
    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 Decision2019-11-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-11
    P. End of Trial
    P.End of Trial StatusOngoing
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