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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2018-002574-52
    Sponsor's Protocol Code Number:1698-301-007
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-04-02
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-002574-52
    A.3Full title of the trial
    A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants with Open-Angle Glaucoma or Ocular Hypertension
    A.4.1Sponsor's protocol code number1698-301-007
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03850782
    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 SponsorAbbVie Deutschland GmbH & Co. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd.
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-mailglobal-clinical-trials@abbvie.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 Sustained Release (SR), Implant
    D.3.2Product code AGN-192024
    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 Yes
    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 or Ocular Hypertension
    E.1.1.1Medical condition in easily understood language
    Open-Angle Glaucoma or Ocular Hypertension
    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 LLT
    E.1.2Classification code 10030856
    E.1.2Term Open-angle glaucoma
    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 PT
    E.1.2Classification code 10030043
    E.1.2Term Ocular hypertension
    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 duration of IOP-lowering effect of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
    E.2.2Secondary objectives of the trial
    To evaluate the safety of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Participant must be at least 18 years of age at the time of signing the informed consent;
    -Male or female;
    -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]);
    -Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow up period;
    -A female participant is eligible to participate if she is not pregnant (ie, has a negative urine pregnancy result at Baseline), not breastfeeding, and at least one of the following conditions applies:
    a. Not a WOCBP as defined in Appendix 7 of the protocol
    OR
    b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 7 of the protocol during the study period
    - Participant is willing to withhold his/her IOP treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk
    Note: If participants cannot discontinue their currently prescribed therapy for up to 8 weeks to meet the Washout period for study entry, the investigator may switch the participant’s medication to one that requires a shorter washout interval during the washout of the original medication.
    - Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
    - In the investigator’s opinion, participant’s IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)
    - Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in the study eye, requiring IOP-lowering treatment;
    -In the investigator’s opinion, the study eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy if medication was taken as directed;
    -The iridocorneal angle in the study eye must be, in the opinion of the investigator, able to safely receive at least 1 Bimatoprost SR implant using the following criteria:
    a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle
    b. Peripheral anterior chamber depth by Van Herick examination ≥ ½ corneal thickness;
    -At the Baseline visit, participant has been appropriately washed out of all IOPlowering medications;
    -At the Baseline visit (9:00 AM ± 1 hour), IOP of ≥ 22 and ≤ 34 mm Hg in the study eye;
    -Central corneal endothelial cell density by specular microscopy deemed acceptable, in the opinion of the investigator (at Screening, a minimum endothelial cell density of 2000 cells/mm2 in the study eye by automated analysis);
    -At the Baseline visit: BCVA (Snellen equivalent, by manifest refraction) of 20/50 or better in the study eye and 20/100 or better in the fellow eye;
    E.4Principal exclusion criteria
    -Uncontrolled systemic disease;
    -Females who are pregnant, nursing, or planning a pregnancy during the study OR who are WOCBP and will not follow contraceptive guidance;
    -Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine);
    -Participants who have a condition or are in a situation which, in the investigator’s opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant’s participation in the study; Note: the investigator should consider a participant´s overall health condition, including COVID-19 infection. This should include assessing if the patient is suspected of; quarantinied for; or diagnosed with active COVID-19 infection, and whether or not the participant has any symptoms.
    -Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit;
    - Previous use of commerically available Bimatoprost SR in the study eye, concurrent enrollment in another Allergan Bimatoprost SR study ; or
    previous enrollment in which a Bimatoprost SR implant was received in the eye Note: Note: Participants with an eye that has not been
    previously treated with Bimatoprost SR or participants previously enrolled in Bimatoprost SR studies 192024-091/-092, and -041D who
    have an eye that was not treated with Bimatoprost SR in that study may be enrolled, provided that the eye that did not receive Bimatoprost SR
    meets entry criteria for this study.
    -Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator)
    Note: Participants receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at the investigator’s discretion;
    -History of previous laser trabeculoplasty in the study eye;
    -History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye;
    -The following surgical history in the study eye:
    a. History or evidence of complicated cataract/lens surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc.) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc.)
    Note: history of uncomplicated cataract surgery is not an exclusion
    b. History of phakic IOL insertion for refractive error correction;
    -Intraocular surgery (including cataract surgery) in the study eye within the 6 months prior to treatment administration (Day 1 Cycle 1 Administration);
    -Any history of corneal graft, including partial grafts (eg, Descemet’s Stripping Endothelial Keratoplasty [DSEK], Descemet’s Membrane Endothelial Keratoplasty [DMEK]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye;
    -Central corneal thickness of < 480 or > 620 micrometers in the study eye;
    E.5 End points
    E.5.1Primary end point(s)
    Duration of effect of Bimatoprost SR
    E.5.1.1Timepoint(s) of evaluation of this end point
    at each study visit starting baseline
    E.5.2Secondary end point(s)
    Adverse events; visual fields; visual acuity; macroscopic bulbar conjunctival hyperemia; slit-lamp biomicroscopic assessments; dilated ophthalmoscopic assessments (including optic disc assessment); contact ultrasound pachymetry; gonioscopy; specular microscopy
    E.5.2.1Timepoint(s) of evaluation of this end point
    at each study visit
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    Argentina
    Australia
    South Africa
    United States
    France
    Poland
    Sweden
    Bulgaria
    Czechia
    Germany
    Italy
    Denmark
    Hungary
    Ireland
    Russian Federation
    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
    A participant is considered to have completed the study if he/she has completed all visits of the study to Month 30, or if the participant has early exited. Participants who receive nonstudy IOP-lowering treatment (rescue) in the Bimatoprost SR treated eye may early exit the study at least 12 months after the participant’s last Bimatoprost SR administration, if there are no safety concerns in the opinion of the investigator. All other participants will exit at the Month 30/Study Exit visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 290
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 200
    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 state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 147
    F.4.2.2In the whole clinical trial 490
    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)
    No interventions after the end of the study are planned; participants will be treated per SOC by their health care provider.
    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 Decision2019-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-11
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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