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    Summary
    EudraCT Number:2020-003515-10
    Sponsor's Protocol Code Number:BP41783
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-01-20
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2020-003515-10
    A.3Full title of the trial
    A LONGITUDINAL, BIOMARKER STUDY OF ANTI-VEGF, TO EXPLORE THE RELATIONSHIP BETWEEN AQUEOUS HUMOR COMPOSITION AND MULTIMODAL RETINAL IMAGING IN NEOVASCULAR AGE-RELATED MACULAR DEGENERATION AND DIABETIC MACULAR EDEMA
    LONGITUDINÁLNÍ STUDIE BIOMARKERŮ INHIBITORŮ VEGF ZKOUMAJÍCÍ VZTAH MEZI SLOŽENÍM KOMOROVÉ VODY A MULTIMODÁLNÍMI SNÍMKY SÍTNICE PŘI VLHKÉ FORMĚ VĚKEM PODMÍNĚNÉ MAKULÁRNÍ DEGENERACE A DIABETICKÉM MAKULÁRNÍM EDÉMU (STUDIE LONGITUDE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To Study Aqueous Humor Composition and Retinal Imaging Features in Response to Anti-VEGF in Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema
    STUDIE BIOMARKERŮ INHIBITORŮ VEGF ZKOUMAJÍCÍ VZTAH MEZI SLOŽENÍM KOMOROVÉ VODY A MULTIMODÁLNÍMI SNÍMKY SÍTNICE PŘI VLHKÉ FORMĚ VĚKEM PODMÍNĚNÉ MAKULÁRNÍ DEGENERACE A DIABETICKÉM MAKULÁRNÍM EDÉMU
    A.4.1Sponsor's protocol code numberBP41783
    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 SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    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 supportF. Hoffmann-La Roche Ltd
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF. Hoffmann-La Roche Ltd
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.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 Eylea®
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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.3.1Product nameAflibercept
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 INNAFLIBERCEPT
    D.3.9.1CAS number 862111-32-8
    D.3.9.3Other descriptive nameAFLIBERCEPT
    D.3.9.4EV Substance CodeSUB26987
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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
    Treatment Naïve Neovascular Age-Related Macular Degeneration (nAMD) and Treatment Naïve diabetic macular edema (DME)
    E.1.1.1Medical condition in easily understood language
    nAMD is an eye disease particularly affects the center of sharp vision (e.g affects reading or driving). DME is a complication of diabetes and causes problem in vision (e.g blurred or wavy vision).
    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 SOC
    E.1.2Classification code 10015919
    E.1.2Term Eye disorders
    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 explore aqueous humor (AH) biomarkers and multimodal imaging features at baseline and over time with and without relation to treatment response
    • To explore association of genetic polymorphisms with AH biomarkers, multimodal imaging features, and treatment response
    • To explore whether the biomarkers identified in AH related to treatment response show a similar relationship to treatment response when measured in blood
    • To describe the relationship between biomarkers of interest in AH and blood at all timepoints tested
    • To explore the relationship between biomarkers and relevant biochemical pathways in AH at all timepoints tested
    • To evaluate machine-learning models trained on historic study data for prediction of treatment response
    E.2.2Secondary objectives of the trial
    NA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria for All Participants
    • Investigator deems collection of > 90 micro liter AH is feasible and safe and participant consents to AH collection
    • Participants who are treatment-naïve in the study eye (e.g., have not received previous treatment with any anti-VEGF IVT, or any corticosteroids periocular or IVT, or any fluocinolone acetonide IVT implant [i.e. Iluvien or Retisert], or laser or verteporfin photodynamic therapy and no such treatment planned for the time between screening and Day 1).
    • Decreased BCVA is attributable primarily to nAMD or DME, respectively; with an Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letter score of 75 to 20 letters
    • Clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis and for follow-up
    • Only one eye can be the study eye; if both eyes are eligible, the eye with the lower BCVA at Day 1 becomes the study eye. If both eyes have the same BCVA, the right eye will be defined as the study eye
    • Female Participants; A female is eligible to participate if she is not pregnant (see Appendix 4 of the protocol), not breastfeeding, and at least one of the following conditions applies:
    o Women of non-childbearing potential (WONCBP), as defined in Appendix 4 of the protocol
    AND/OR
    o Women of childbearing potential (WOCBP), who:
    - Agree to remain abstinent (refrain from heterosexual intercourse) or have to use effective contraception during treatment and for at least 3 months after the last IVT injection of aflibercept.
    - Have a negative pregnancy test (urine) at Day 1.
    Inclusion Criteria for nAMD Population
    • Age>= 50 years
    Ocular Inclusion Criteria for Study Eye with nAMD
    • Participants diagnosed with nAMD within the last 12 months.
    • Participants with subfoveal or juxtafoveal CNV lesion of all types
    • Study eye is eligible to be treated with aflibercept and treatment can be scheduled according to the prescribing information for nAMD as per label
    Inclusion Criteria for DME Population
    • Age >= 18 years
    • Diagnosis of DM (type 1 or type 2), as defined by the World Health Organization and/or American Diabetes Association
    Ocular Inclusion Criteria for Study Eye with DME
    • Participants diagnosed with DME within the last 12 months
    • DME defined as thickening on spectral domain optical coherence tomography (SD-OCT) involving the center of the macula: CST of ≥ 325 µm with Spectralis® (Heidelberg Engineering, Heidelberg, Germany)
    • Study eye is eligible to be treated with aflibercept, and treatment can be scheduled according to the prescribing information for DME as per label in the study eye
    E.4Principal exclusion criteria
    Exclusion Criteria for All Participants
    • Any known hypersensitivity to any contrast media, aflibercept, dilating eye drops, or any of the anesthetics and antimicrobial drops used
    • Pregnant or breastfeeding women, or women intending to become pregnant during the study and during 3 months after the study
    • Uncontrolled blood pressure is defined as systolic > 180 mm Hg and/or diastolic > 100 mm Hg
    • Renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis within six months prior to Day 1 or anticipated to require hemodialysis or peritoneal dialysis at any time during the study
    • History of or currently active other diseases, other non-diabetic metabolic dysfunction, including viral and/or bacterial infections that might affect interpretation of the results of the study, or does not allow the participant to follow the visit schedule, or renders the participant at high risk for aflibercept treatment complications in the opinion of the Investigator. Note: Participants who tested positively for COVID-19/SARS-CoV-2 at any time prior to Day 1 are excluded, regardless of their vaccination status and regardless of presence of COVID-19 symptoms
    • Active cancer within the past 12 months prior to Day 1
    • Any major illness or major surgical procedure one month prior to Day 1
    • Stroke or myocardial infarction within 12 months prior to Day 1
    • Participant has received blood transfusion within three months prior to screening
    • Any febrile illness within one week prior to Day 1
    • Participants who are currently enrolled in or have participated in any other clinical study involving an investigational product or device, or in any other type of medical research, within three months or 5 half-lives (whichever is longer) prior to Day 1 and up to completion of the study
    • Any illness that causes immunosuppression or any treatment that leads to immunosuppression within 5 half-lives prior to the Day 1
    • Use of any systemic corticosteroids within one month prior to Day 1
    • Substance abuse within 12 months prior to screening, in the Investigator's judgment
    • Any prior or concomitant systemic anti-VEGF treatment within 6 months or 5 half-lives (whichever is longer) prior to Day 1
    • Use of systemic medications known to be toxic to the lens, retina, or optic nerve used during the six-month period or 5 half-lives (whichever is longer) prior to Day 1 or likely need to be used.
    • Any intraocular surgery in the study eye within three months prior to Day 1 or any planned surgery during the study
    • Aphakia or implantation of intraocular lens outside of the capsular bag in the study eye
    • Treatment for dry eye disease (except eye Lubricants) in the study eye within 1 month prior to Day 1
    • Any active ocular or periocular infections
    • Any presence of active intraocular inflammation or any history of intraocular inflammation, idiopathic, infectious, or noninfectious uveitis
    • History of vitreoretinal surgery/pars plana vitrectomy, corneal transplant, or radiotherapy
    • Any current ocular condition in the study eye for which, in the opinion of the Investigator, VA loss would not improve from resolution of macular edema
    • Uncontrolled glaucoma in the study eye
    • History of glaucoma surgery in the study eye
    • Any treatment of the study eye with anti-inflammatory eye drops within 1 month prior to Day 1
    • Previous treatment with Iluvien or Retisert in fellow eye (non-study eye)
    • If participants have been treated with any periocular or IVT corticosteroids in the fellow eye, the following washout periods prior to Day 1 apply:
    o Triamcinolone: 6 months
    o Ozurdex (dexamethasone IVT implant): 6 months
    • Participants are currently receiving treatment with Beavu or Avastin in the fellow eye and are unwilling to switch to a protocol-allowed fellow eye treatment during the study
    • Any current or history of ocular or intraocular condition that may confound assessment of the macula or affect central vision or could either:
    o Require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition; or Preclude any visual improvement due to substantial structural damage
    Exclusion Criteria for nAMD Population
    Ocular Exclusion Criteria for Study Eye with nAMD
    • CNV due to causes other than AMD
    • Retinal pigment epithelial tear involving the macula
    • Central serous chorioretinopathy
    • Spherical equivalent of the refractive error demonstrating more than eight diopters of myopia
    Exclusion Criteria for DME Population
    • Currently untreated DM or previously untreated participants who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
    • Hemoglobin A1c (HbA1c) >10%. One rescreening for this criterion is permitted after 8 weeks if the HbA1c value at screening is >10% and <11%
    Ocular Exclusion Criteria for Study Eye with DME
    • Any history of or active proliferative DR (PDR)
    • History of or ongoing rubeosis iridis
    E.5 End points
    E.5.1Primary end point(s)
    1. Values of multimodal imaging features at all timepoints tested
    2. BCVA score at all timepoints tested
    3. Values of AH biomarkers at all timepoints tested
    4. Genotypes
    5. Values of selected blood biomarkers at all timepoints tested
    6. Values of AH biomarkers of interest at all timepoints tested
    7. Values of blood biomarkers of interest at all timepoints tested
    8. Pathway analysis based on values of AH biomarkers at all timepoints tested
    9. Model performance for predicting treatment response based on clinical, imaging and biomarker baseline values
    E.5.1.1Timepoint(s) of evaluation of this end point
    1-2. At baseline/ Day 1, at Week 8 and at Week 24 (for nAMD), and baseline, at Week 16 and at Week 24 (for DME)
    3. At baseline/ Day 1, at Week 8 and at Week 24 (for nAMD), and baseline, at Week 16 and at Week 24 (for DME)
    4. At Baseline/ Day 1 or at other scheduled visit
    5-7. At baseline/ Day1, at Week 8 and at Week 24 (for nAMD), and baseline, at Week 16 and at Week 24 (for DME)
    8-9. From baseline/ Day 1 to Week 24
    E.5.2Secondary end point(s)
    NA
    E.5.2.1Timepoint(s) of evaluation of this end point
    NA
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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
    to explore the composition of aqueous humor and features of multimodal retinal imaging
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.7.1Other trial design description
    biomarker study
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Colombia
    Czechia
    Italy
    Korea, Republic of
    Poland
    Russian Federation
    United States
    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 the last scheduled procedure shown in the Schedules of Activities (SoAs, Section 1.3). The last activity includes a safety follow-up call 5 to 7 days after the final AH sampling and IVT aflibercept administration.
    The end of the study is defined as the date of the last visit of the last participant (LVLP) occurs.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 150
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 50
    F.4.2.2In the whole clinical trial 200
    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 Sponsor does not intend to provide any IMP or other study interventions to participants after conclusion of the study or any earlier participant withdrawal.
    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 Decision2021-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-02-03
    P. End of Trial
    P.End of Trial StatusOngoing
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