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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2014-003229-17
    Sponsor's Protocol Code Number:Protocol1
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-08-01
    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 number2014-003229-17
    A.3Full title of the trial
    To compare the effect of Eylea given every other month after three injections to treatment with a gradual extension intervals. and examine retinal function with electroretinography (ERG) in patients with wet AMD (age related macular edema)
    Att jämföra effekten av Eylea vid varannan månads behandling efter tre månatliga injektioner med behandling med gradvis utökande behandlingsintervall från början och samtidigt undersöka retinal funktion med elektroretinografi hos patienter med våt åldersrelaterad makuladegeneration.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    To compare two different treatment intervals when treating patients with wet macular disease with Eyelea and to examine the effect of the treatment on the sight cells.
    Att jämföra två olika behandlings intervall med eylea för våt AMD och att medels ERG (elektrofysiologi) se effekten på syncellernas funktion
    A.4.1Sponsor's protocol code numberProtocol1
    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 SponsorInst of OPhthalmology, Lund University
    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 supportInst of OPhthalmology, Lund University
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInst of OPhthalmology, Lund university
    B.5.2Functional name of contact pointEye clinic, University Hospital
    B.5.3 Address:
    B.5.3.1Street AddressEye clinic, SUS
    B.5.3.2Town/ cityLund
    B.5.3.3Post code22185
    B.5.3.4CountrySweden
    B.5.4Telephone number+4646171650
    B.5.6E-mailmonicaladrian@gmail.com
    D. IMP Identification
    D.IMP: 1
    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 Aflibercept
    D.2.1.1.2Name of the Marketing Authorisation holderBayer
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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.3.2Product code SO1LAO5
    D.3.4Pharmaceutical form Intravitreal implant in applicator
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    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) Yes
    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
    To evaluate if Aflibercept given every eighth week from start after an initial loading dose in age-related macular degeneration (AMD), is as effective as dosing as "Treat and extend" where treating intervalls are prolonged after stability in visual acuity is achieved. Followed for 18 months.


    The secondary objective is to evaluate the safety of Aflibercept assessed with ERG, and a quality of life questioner will be put to all patients at start and at follow-up after 18 months.
    Primär målsättning: Att undersöka om Aflibercept doserat varannan månad efter tre initial månatliga injektioner är lika effektivt som att dosera enligt treat-and-extend regimen där intervallen förlängs efter att maximal synskärpa uppnåtts hos patienter med våt AMD under 18 månader.
    Sekundär målsättning: Undersöka retinala funktionen efter injektion av Aflibercept mätt med ERG, samt ett livskvalitetsformulär kommer att distribueras till patienterna före/efter behandling.
    E.1.1.1Medical condition in easily understood language
    To evaluate if Eylea injections into the eye for wet macular degenerations, can be extended and given with longer intervals.
    Att undersöka om intervallen mellan Eylea sprutat i ögat vid våt maculasjukdom kan förlängas
    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
    The primary objective is to evaluate if Aflibercept given every eighth week from start is as effective as given with an initial loading dose in age-related macular degeneration (AMD), after 6 months and after 18 months administered with a treat-and-extend regimen after the first 6 months.


    Primär målsättning: Att undersöka om Aflibercept doserat varannan månadvecka efter tre initial månatliga injektioner är lika effektivt so m att dosera enligt treat-and-extend regimen där intervallen förlängs efter att maximal synskärpa uppnåtts hos patienter med våt AMD under 18 månaders uppföljning.
    E.2.2Secondary objectives of the trial
    The secondary objective is to evaluate the safety of Aflibercept assessed with ERG, and a quality of life questioner will be put to all patients at a number of occasions throughout the study to evaluate these patients’ quality of life.
    Sekundär målsättning: Vi vill också titta på den retinala funktionen efter injektion av Aflibercept mätt med ERG, samt ett livskvalitetsformulär kommer att distribueras till patienterna vid ett flertal tillfällen under studien för att undersöka upplevelsen av behandlingen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Men and women age >50 years having an active subfoveal choroidal neovascularisation (CNV). Clinical indicated due to CNV with a visual impairment down to 0.1.
    Signed informed consent form
    • Corrected distance logMAR visual acuity more than 25 letters read on a standard ETDRS chart at 1 metre.
    • Age ≥ 50 years of either gender
    • Any component of neovascularlesion (CNV, Blood, serious pigment epithelial detachment, elevated blocked fluorescence) involving the centre of the fovea.

    Eligibility criteria for study eye
    • Study eye must meet the following criteria for entry into the study:
    • Newly diagnosed, angiographically documented, previously untreated, active CNV lesion (i.e., leakage on fluorescein angiography AND subretinal, intraretinal, or sub-RPE fluid on OCT) secondary to age-related macular degeneration.
    • Best corrected visual acuity in the study eye, using e-ETDRS testing, between 20/25 and 20/320 (Snellen equivalent), inclusive. Only one eye will be enrolled in the Study. If both eyes are eligible, the patient and study ophthalmologist will select the eye for entry.
    • The CNV or sequela of the CNV (i.e., pigment epithelium detachment, subretinal or sub-RPE hemorrhage, blocked fluorescence, macular edema, or subretinal sub-RPE or intraretinal fluid) must involve the center of the fovea.
    • The total area of fibrosis must comprise less than 50% of the total lesion.
    • No previous treatment for CNV in the study eye


    A. Män och kvinnor > 50 år som kommer till kliniken med kliniskt signifikanta maculaödem samt kärlnybildningar verifierat med kontrastundersökning (fluoresceinangiografi) på sedvanligt sätt kommer tillfrågas om de vill ingå i studien.
    • Patienter med alla slag av våt AMD (minimal classic, predominantly classic, okult membran) och ej tidigare behandlade samt visus ≥ 0.1 kommer inkluderas.
    Beslut om att behandla med Aflibercept ska ha tagits innan inklusion i studien övervägs.
    Patienten kommer informeras nogsamt, få möjlighet till att ställa frågor och sedan signera informed consent.
    Enbart ett öga kommer att erbjudas behandling.
    Om båda ögonen har liknande problem kommer det ögat, som har de mest aktuella symptomen att behandlas
    E.4Principal exclusion criteria
    Ocular concomitant / previous conditions / diseases
    • Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
    • Active intraocular inflammation (grade trace or above) in either eye
    • Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
    • History of uveitis in either eye
    • Structural damage within 0.5 disc diameter of the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques
    • Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 24-month study period, including cataract, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., AMD, ocular histoplasmosis, or pathologic myopia)
    • Uncontrolled glaucoma in either eye (IOP > 24 mmHg on medication or according to investigator’s judgment)
    • Neovascularization of the iris in either eye
    • Evidence of vitreomacular traction in either eye
    • Active proliferative diabetic retinopathy in the study eye
    • Patients who are monocular or have a BCVA score in the non-study eye (fellow eye)  24 letters (approximate Snellen equivalent of 20/320) at Visit 1
    B. Exklusionkriterier
    B1. Allmänna exklusionkriterier
    • Gravida och ammande kvinnor.
    • Kvinnor i fertil ålder skall ha adekvat antikonception
    B2. Specifika exklusionskriterier
    • Patienter med aktiva eller misstänkta infektioner i eller runt ögat.
    • Patienter med aktiv svår intraokulär inflammation
    • Patienter med okontrollerat IOP (intraokulärt tryck) (>25 mm Hg trots behandling)
    • Genomgången intraokulär kirurgi de senaste 3 månaderna (risk för försämrad sårläkning)
    • Tidigare behandling för näthinnesjukdom såsom trombos eller diabetesretinopati
    E.5 End points
    E.5.1Primary end point(s)
    Efficacy
    • Mean change in VA at 18 months (non-inferiority limit of 5 letters)
    • Change in retinal thickness on OCT

    medel förändring i synskärpa efter 18 mån
    Förändring i OCT (näthinnetjocklek)
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 18 months follow up
    Eftre 18 månader
    E.5.2Secondary end point(s)
    Secondary:
    • ERG
    • Quality of Life questioner, VFQ 25
    • Reading speed, eye movement,(central visual field?)
    ERG (elektroretinogram
    Livskvalitetsfrågor VFQ 25
    Läshastighet
    E.5.2.1Timepoint(s) of evaluation of this end point
    After 18 months follow-up
    Efter 18 månader
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state40
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 40
    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)
    Patinets will continue to be followed and treated accordingly to the disease outcome
    Patienterna kommmer fortsättningsvis följas och behandlas vid behov enligt gängse kliniska 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 Decision2014-10-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
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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
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