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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2018-004438-14
    Sponsor's Protocol Code Number:SAHLVE
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2019-05-09
    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 ConcernedSweden - MPA
    A.2EudraCT number2018-004438-14
    A.3Full title of the trial
    See below
    The Sahlgrenska anti-VEGF (SAHLVE) study – en prospektiv randomiserad dubbelblind jämförelse mellan bevacizumab och aflibercept hos patienter med våt åldersrelaterad makuladegeneration
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    See below
    Studie som jämför läkemedel vid ögoninjektioner mot den våta formen av AMD (åldersrelaterade förändringar i gula fläcken)
    A.3.2Name or abbreviated title of the trial where available
    SAHLVE
    A.4.1Sponsor's protocol code numberSAHLVE
    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 SponsorVästra Götalandsregionen
    B.1.3.4CountrySweden
    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 supportVästra Götalandsregionen
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVästra Götalandregionen
    B.5.2Functional name of contact pointMadeleine Zetterberg
    B.5.3 Address:
    B.5.3.1Street AddressÖgonsjukvård, Sahlgrenska universitetssjukhuset
    B.5.3.2Town/ cityMölndal
    B.5.3.3Post code43180
    B.5.3.4CountrySweden
    B.5.4Telephone number+46313433255
    B.5.6E-mailmadeleine.zetterberg@vgregion.se
    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 Avastin
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    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 INNBEVACIZUMAB
    D.3.9.1CAS number 216974-75-3
    D.3.9.4EV Substance CodeSUB16402MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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) Yes
    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.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 Eylea
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection
    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.3.9.3Other 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) Yes
    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
    See below
    Våt (neovaskulär) åldersrelaterad makuladegeneration (AMD)
    E.1.1.1Medical condition in easily understood language
    See below
    Den våta formen av åldersrelaterade förändringar i gula fläcken
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    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
    See below
    Att undersöka om patienter som behandlas för våt AMD med intravitreal injektion med bevacizumab efter två år behöver fler injektioner med bibehållet terapisvar jämfört med patienter som behandlas med intravitreal injektion med aflibercept.
    E.2.2Secondary objectives of the trial
    See below
    Att undersöka om det finns skillnad hos patienter som behandlas för våt AMD med intravitreal injektion med bevacizumab jämfört med aflibercept efter två år (jämfört med vid baseline) med avseende på:

    bästa-korrigerade synskärpa (långt och nära håll)

    makulatjocklek (Central Retinal Thickness; CRT)

    synrelaterad livskvalitet

    recidivintervall (högst antal veckor från senaste injektion till recidiv)

    durabilitet (längsta påvisade inaktiva intervallet)

    kostnadseffektivitet
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    See below
    För att inkluderas i studien måste deltagaren uppfylla följande kriterier:

    Signerat informerat samtycke.

    ≥50 år, oavsett kön.

    Diagnosticerats med den våta formen av åldersrelaterad makuladegeneration genom diagnosticerade neovaskulära kärlmembran med OCT-A och vid behov även FA/ICG, enligt klinisk rutin.

    Synskärpa långt håll ≥34 (ETDRS) på det aktuella studieögat.
    E.4Principal exclusion criteria
    See below
    Deltagare får inte inkluderas i studien om något av följande kriterier är uppfyllda:

    Annan ögonsjukdom i det aktuella studieögat som påverkar synskärpan eller möjlighet att undersöka ögonbotten, enligt prövarens bedömning.

    Tidigare erhållit behandling för den våta formen av åldersrelaterad makuladegeneration.

    Diagnosticerad med diabetes (alla typer).

    Degenerativt tillstånd i makula som förhindrar synförbättring såsom central areolär atrofi eller annan uttalad torr AMD eller fibros, i det aktuella studieögat.

    Annan koroidal neovaskularisation (CNV) av typen PCV eller p.g.a. grav myopi dvs ≥ -6,0 dioptrier (D) eller sekundärt till annan retinal sjukdom, i det aktuella studieögat.

    Oreglerat intraokulärt tryck (IOP) >30 mmHg trots farmakologisk behandling i det aktuella studieögat.

    Har haft stroke eller hjärtinfarkt ≤6 månader sedan.

    Oförmåga att ta till sig information (t.ex. på grund av demenssjukdom) eller oförmåga att genomföra undersökningar (t.ex. ETDRS-synprövning), enligt prövarens bedömning.

    Oförmåga att ta till sig muntlig och skriftlig information på svenska (i behov av tolk).

    Ingår i annan interventionsstudie.

    Fertil kvinna dvs. kvinna som har haft menstruation senaste 12 månaderna eller inte har genomgått permanent sterilisering (hysterektomi, bilateral salpingektomi eller bilateral ooforektomi).
    E.5 End points
    E.5.1Primary end point(s)
    See below
    Antal injektioner
    E.5.1.1Timepoint(s) of evaluation of this end point
    See below
    Primär endpoint beräknas efter fyra år.
    E.5.2Secondary end point(s)
    See below
    Bästa-korrigerade synskärpa på långt håll (ETDRS), enhet: score (anges i heltal).

    Bästa-korrigerade synskärpa på nära håll (LIX), enhet: textstorlek i ”p” (anges i heltal).

    Makulatjocklek (CRT), enhet: µm (anges i heltal) .

    Synrelaterad livskvalitet (NEI VFQ-25), enhet: score för sub-scales och total score (anges i heltal).

    Recidivintervall (högsta antal veckor från senaste injektion till recidiv) vid första respektive sista recidivet, enhet: veckor (anges i heltal)

    Durabilitet (längsta påvisade inaktiva intervallet), enhet: veckor (anges i heltal)

    Kostnadseffektivitet: cost-per-QALY mäts med enkät EQ-5D, enhet: QALY (quality-adjusted life years).

    Kostnadsnytttoanalys: kostnad per effekt där effekten mäts i EQ-5D och NEI VFQ-25, enhet: ICER (inkrementell kostnadseffektivitetskvot).
    E.5.2.1Timepoint(s) of evaluation of this end point
    See below
    Sekundär endpoint beräknas efter fyra år.
    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 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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) Yes
    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 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
    End of study is after the last visit of the last subject (LVLS)
    Studieslut är när sista patienten i studien har genomfört sitt sista besök.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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: 402
    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 state402
    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)
    See below
    Studiepatienten följs och får fortsatt behandling med ordinarie behandlingsregim och läkemedel, enligt klinisk rutin.
    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 Decision2019-06-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-04
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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