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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7312   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:2016-004119-11
    Sponsor's Protocol Code Number:SPECT
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-11-09
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2016-004119-11
    A.3Full title of the trial
    Study on half-dose Photodynamic therapy versus Eplerenone in chronic CenTRAl serous chorioretinopathy (SPECTRA trial)
    Studie naar halve dosis fotodynamische therapie versus eplerenon bij chronische centrale sereuze chorioretinopathie (SPECTRA studie)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Photodynamic therapy versus eplerenone in chronic central serous chorioretinopathy
    Fotodynamische therapie versus eplerenon bij chronische centrale sereuze chorioretinopathie
    A.3.2Name or abbreviated title of the trial where available
    SPECTRA
    SPECTRA
    A.4.1Sponsor's protocol code numberSPECT
    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 SponsorLeiden University Medical Center
    B.1.3.4CountryNetherlands
    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 supportLeiden University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLeiden University Medical Center
    B.5.2Functional name of contact pointClinical Trial Information
    B.5.3 Address:
    B.5.3.1Street AddressAlbinusdreef 2
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333ZA
    B.5.3.4CountryNetherlands
    B.5.4Telephone number31715299431
    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 eplerenone
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameeplerenone
    D.3.2Product code SPECT
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeplerenone
    D.3.9.1CAS number 107724-20-9
    D.3.9.2Current sponsor codeSPECT
    D.3.9.3Other descriptive nameEPLERENONE
    D.3.9.4EV Substance CodeSUB06574MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number25 to 50
    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
    Chronic central serous chorioretinopathy
    Chronische centrale sereuze chorioretinopathie
    E.1.1.1Medical condition in easily understood language
    Chronic CSC
    Chronische serosa
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10063118
    E.1.2Term Chorioretinopathy
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate whether half-dose PDT treatment leads to a higher percentage of cCSC patients with SRF on OCT at baseline, achieving an absence of this SRF on OCT as compared to eplerenone treatment.
    Onderzoeken of halve dosis fotodynamische therapie in cCSC patiënten met subretinaal vocht op OCT tijdens het Baseline bezoek leidt tot een hoger percentage patiënten met een afwezigheid van dit vocht, in vergelijking met eplerenon behandeling.
    E.2.2Secondary objectives of the trial
    To investigate the clinical outcome comparing half-dose PDT treatment with eplerenone treatment in patients with SRF due to active leakage in cCSC, based on evaluation of best-corrected visual acuity (BCVA), retinal sensitivity on microperimetry, and subjective scores on the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
    Onderzoeken van de klinische uitkomst van behandeling van cCSC patiënten met subretinaal vocht op OCT door actieve lekkage, middels halve dosis fotodynamische therapie versus middels eplerenon: evaluatie op basis van best-gecorrigeerde visus, retinale sensitiviteit bij onderzoek middels microperimetrie, en subjectieve scores bij beantwoorden van de National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    This study will enroll subjects with cCSC with active leakage of fluid to under the retina as evidenced on OCT scanning and further supported by findings on FA and ICGA, in at least 1 eye, who visit the outpatient clinic of the Department of Ophthalmology of the Radboud University Medical Center, the Academic Medical Center Amsterdam, or the Leiden University Medical Center. If both eyes are eligible, then the eye with the longer duration of disease will be used as the study eye, except in cases where the disease is present > 18 months. In the latter case, which is an exclusion criterion, the other eye will be eligible for inclusion if the disease is active for < 18 months in that eye. If the non-study eye also has active disease, the choice to treat and the type of treatment in this eye may be chosen freely at the discretion of the responsible ophthalmologist.
    Before enrolment, each subject must meet all of the following inclusion criteria and none of the exclusion criteria, and agree to comply with the study requirements including completion of all of the study visits.

    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    - Age of ≥ 18 years of age and able to give written IC;
    - Active cCSC;
    - Subjective visual loss > 6 weeks, interpreted as onset of active disease;
    - Foveal SRF on OCT, at Baseline Examination;
    - ≥1 ill-defined hyperfluorescent leakage areas on FA with RPE window defect(s) that are compatible with cCSC;
    - Hyperfluorescent areas on ICGA.
    CCSC patiënten met actieve lekkage van vocht naar onder het netvlies, in minimaal één oog en bewezen op OCT en verder ondersteund door bevindingen op FA en ICGA, kunnen worden geïncludeerd in één van de drie deelnemende studiecentra. Wanneer beide ogen van een patiënt zouden kunnen worden geïncludeerd, wordt het oog gekozen waarin de ziekteduur het langst is (tenzij die duur >18 maanden is). Het oog dat in dat geval niet in de studie wordt geïncludeerd, kan worden behandeld op basis van de expertise van de behandelend oogarts.

    Inclusiecriteria voor de studie zijn:
    - Leeftijd van boven de 18 jaar en in staat tot geven van geschreven informed consent;
    - Actieve cCSC;
    - Subjectieve visusklachten gedurende >6 weken, welke geïnterpreteerd zijn als start van actieve ziekte;
    - Foveaal subretinaal vocht op OCT, tijdens Baseline Evaluatie;
    - Eén of meer ziektespecifieke hyperfluorescente lekkage gebieden op FA, met RPE window defecten die compatibel zijn met cCSC;
    - Hyperfluorescente gebieden op ICGA.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria for the study eye will be excluded from participation in this study:
    - Any previous treatments for active CSC;
    - Previous prescription of mineralocorticoid receptor antagonists, for cCSC or for other diseases;
    - Current treatment with corticosteroids (topical or systemic), corticosteroid use within 3 months before possible start of trial treatment, or anticipated start of corticosteroid treatment within the first 2 years from the start of the trial period;
    - Evidence of another diagnosis that can explain serous SRF or visual loss;
    - BCVA < 20/200 (Snellen equivalent);
    - Profound chorioretinal atrophy in central macular area on ophthalmoscopy and OCT;
    - Myopia > 6D;
    - Visual loss and/or serous detachment on OCT < 6 weeks;
    - Continuous and/or progressive visual loss > 18 months or serous detachment on OCT > 18 months;
    - No hyperfluorescence on ICGA;
    - Intraretinal edema on OCT;
    - (relative) Contraindications for FA or ICGA;
    - (relative) Contraindications for PDT treatment (pregnancy, porphyria, severely disturbed liver function). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during screening;
    - (relative) Known contraindications for initiation of eplerenone treatment (hyperkalemia, abnormal renal clearance, severe hepatic insufficiency (Child-Pugh C), type 2 diabetes mellitus with microalbuminuria, concomitant use of potassium supplements, potassium-sparing diuretics, strong CYP3A4 inhibitors, or the combination of an ACE-inhibitor and an angiotensin receptor blocking agent). Pregnancy will not be routinely tested in female patients, but the possibility of pregnancy will be discussed during screening;
    - Soft drusen in treated eye or fellow eye, signs of choroidal neovascularization on ophthalmoscopy and/or FA/ICGA of the study eye.

    The previous prescription of oral medication (for example, acetazolamide) for cCSC, except the prescription of previous mineralocorticoid receptor antagonists, is not an exclusion criterion for this study.
    Exclusiecriteria voor deze studie:
    - Elke eerdere behandeling voor actieve cCSC;
    - Eerdere voorschrijving van mineralocorticoïd receptor antagonisten, zowel voor de behandeling van cCSC als voor de behandeling van eerdere ziekte(n);
    - Huidige behandeling met corticosteroïden (topicaal of systemisch), corticosteroïdgebruik binnen drie maanden voor de mogelijke start van trialbehandeling, of voorgenomen start van corticosteroïdbehandeling binnen de eerste twee jaar na start van trialbehandeling;
    - Bewijs van een andere diagnose die het bestaan van sereus subretinaal vocht en/of visusklachten zou kunnen verklaren;
    - Best-gecorrigeerde visus <20/200 (Snellen);
    - Duidelijke chorioretinale atrofie in het centrale maculaire gebied, bij oftalmoscopie en OCT;
    - Myopie >6D;
    - Visusklachten en/of sereuze loslating op OCT van <6 weken;
    - Continue en/of progressieve visusklachten van >18 maanden of een sereuze loslating op OCT van >18 maanden;
    - Geen hyperfluorescente gebieden op ICGA;
    - Intraretinaal oedeem op OCT;
    - (relatieve) contraindicaties voor FA of ICGA;
    - (relatieve) contraindicaties voor PDT behandeling;
    - (relatieve) contraindicatie voor eplerenon behandeling;
    - Zachte drusen in één van beide ogen, tekenen van een choroïdale neovascularisatie, bij oftalmoscopie en/of FA/ICGA van het studieoog.

    Eerdere voorschrijving van orale medicijnen (bijvoorbeeld: acetazolamide) voor cCSC, behalve de voorschrijving van eerdere mineralocorticoïd receptor antagonisten, is geen exclusiecriterium voor inclusie in de studie.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of this study is to assess if there is a difference between half-dose PDT and eplerenone treatment in patients with cCSC, in terms of complete resolution of SRF on OCT. The assessment of this efficacy will be based on the anatomical effect on OCT: absence of SRF versus persistence of SRF, at 3 months after the initiation of treatment.
    Verschil in complete resolutie van subretinaal vocht op OCT (complete resolutie versus persisterend subretinaal vocht) in de patiënten die met fotodynamische therapie behandeld zijn, versus de patiënten die met eplerenon behandeld zijn.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 3 months after the initiation of treatment
    Drie maanden na start van behandeling.
    E.5.2Secondary end point(s)
    As secondary endpoints, we will mainly look at 3 parameters that reflect the patient’s vision-related functioning. These 3 parameters are: a standardized measurement of ETDRS BCVA, a standardized measurement of sensitivity of the macula with microperimetry, and a standardized assessment of the patient’s vision-related quality of life using a validated questionnaire, the NEI-VFQ-25.

    The secondary endpoints that will be assessed as a reflection of functional improvement after treatment include:
    - Number of cross-over treatments (eplerenone after half-dose PDT, and half-dose PDT after eplerenone) needed in each treatment arm;
    - Mean change in ETDRS BCVA in the study eye at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at the Final Evaluation Visit, compared to Baseline Evaluation;
    - Mean change in ETDRS BCVA in the study eye at Evaluation Visit 3 and at Final Evaluation Visit among those with subsequent (cross-over) and those without subsequent treatment;
    - Mean change in retinal sensitivity in the study eye at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at Final Evaluation Visit, compared to Baseline Evaluation;
    - Mean change in the NEI-VFQ-25 questionnaire at Evaluation Visit 1, at – if applicable – Evaluation Visit 2, at Evaluation Visit 3, and at Final Evaluation Visit, compared to Baseline Evaluation;
    - The long-term outcome both after successful treatment and after non-successful treatment (‘success’ is defined as the absence of SRF on OCT at Evaluation Visit 1 (at 3 months after the initiation of treatment));
    - Differences between starting with treatment A with the possibility to switch to treatment B compared to starting with treatment B with the possibility to switch to treatment A;
    - The number of (S)AEs in the 2 different treatment groups.
    Secundaire eindpunten van deze studie zijn drie parameters die het visueel functioneren van patiënten weergeven: gestandaardiseerde meting van best-gecorrigeerde visus in ETDRS letters, gestandaardiseerde meting van maculaire sensitiviteit bij onderzoek middels microperimetrie, en een gestandaardiseerd onderzoek van de kwaliteit van visueel functioneren van patiënten, waarbij gebruikt wordt gemaakt van de NEI-VFQ-25 vragenlijst.

    Secundaire eindpunten van deze studie zijn:
    - Aantal cross-over behandelingen in de twee behandelarmen van de studie;
    - Gemiddelde verandering in best-gecorrigeerde visus in ETDRS letters in het studieoog tijdens Evaluatiebezoek 1 (drie maanden na start van de trialbehandeling), tijdens - indien van toepassing - Evaluatiebezoek 2 (drie maanden na mogelijke cross-over over behandeling binnen de trial), tijdens Evaluatiebezoek 3 (één jaar na start van trial behandeling), en tijdens Evaluatiebezoek 4 (twee jaar na start van trial behandeling) - alle ten opzichte van Baseline Evaluatie;
    - Gemiddelde verandering in best-gecorrigeerde visus in ETDRS letters in het studieoog tijdens Evaluatiebezoek 3 en tijdens het Laatste Evaluatiebezoek, waarbij patiënten met een cross-over behandeling worden vergeleken met patiënten die geen cross-over behandeling binnen de trial ontvingen;
    - Gemiddelde verandering in retinale sensitiviteit bij microperimetrie in het studieoog tijdens Evaluatiebezoek 1 (drie maanden na start van de trialbehandeling), tijdens - indien van toepassing - Evaluatiebezoek 2 (drie maanden na mogelijke cross-over over behandeling binnen de trial), tijdens Evaluatiebezoek 3 (één jaar na start van trial behandeling), en tijdens Evaluatiebezoek 4 (twee jaar na start van trial behandeling) - alle ten opzichte van Baseline Evaluatie;
    - Gemiddelde verandering in de uitkomst van beantwoording van vragen van NEI-VFQ-25, tijdens Evaluatiebezoek 1 (drie maanden na start van de trialbehandeling), tijdens - indien van toepassing - Evaluatiebezoek 2 (drie maanden na mogelijke cross-over over behandeling binnen de trial), tijdens Evaluatiebezoek 3 (één jaar na start van trial behandeling), en tijdens Evaluatiebezoek 4 (twee jaar na start van trial behandeling) - alle ten opzichte van Baseline Evaluatie;
    - Lange termijn uitkomst na succesvolle behandeling en niet-succesvolle behandeling binnen de trial ('succes' is hierbij gedefinieerd als de afwezigheid van subretinaal vocht op OCT tijdens het Eerste Evaluatiebezoek (na 3 maanden na start van behandeling);
    - Verschillen tussen starten met behandeling A en de mogelijkheid is te switchen naar behandeling B, en starten met behandeling B en de mogelijkheid te switchen naar behandeling A;
    - Aantal (S)AEs in de twee verschillende behandelarmen.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At Evaluation Visit 1 (at 3 months after the start of trial treatment), at – if applicable – Evaluation Visit 2 (at 3 months after possible cross-over trial treatment), at Evaluation Visit 3 (one year after the start of trial treatment), and at the Final Evaluation Visit (two years after the start of trial treatment), compared to Baseline Evaluation;
    Tijdens Evaluatiebezoek 1 (drie maanden na start van de trialbehandeling), tijdens - indien van toepassing - Evaluatiebezoek 2 (drie maanden na mogelijke cross-over over behandeling binnen de trial), tijdens Evaluatiebezoek 3 (één jaar na start van trial behandeling), en tijdens Evaluatiebezoek 4 (twee jaar na start van trial behandeling) - alle ten opzichte van Baseline Evaluatie.
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3.1Comparator description
    half-dose verteporfin photodynamic therapy
    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 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 Yes
    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
    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 months0
    E.8.9.1In the Member State concerned 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: 7
    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 state107
    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)
    At the discretion of the treating ophthalmologist.
    Op basis van de expertise van de behandelend oogarts.
    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 Decision2016-11-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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