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    Summary
    EudraCT Number:2012-004555-36
    Sponsor's Protocol Code Number:PLACE
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2012-004555-36
    A.3Full title of the trial
    A prospective randomized controlled multicentre trial comparing half-dose photodynamic therapy (PDT) with high-density subthreshold micropulse laser treatment in patients with chronic central serous chorioretinopathy (CSC).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    PHOTODYNAMIC THERAPY VERSUS MICROPULSE LASER TREATMENT IN CHRONIC CENTRAL SEROUS CHORIORETINOPATHY
    A.4.1Sponsor's protocol code numberPLACE
    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 SponsorCentre Hospitalier Intercommunal de Créteil
    B.1.3.4CountryFrance
    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 supportCentre Hospitalier de CRETEIL
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Hospitalier de CRETEIL
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street Address40 avenue de Verdun
    B.5.3.2Town/ cityCRETEIL
    B.5.3.3Post code94010
    B.5.3.4CountryFrance
    B.5.6E-mailgiuseppe.queques@chicreteil.fr
    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 VISUDYNE
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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
    E.1.1.1Medical condition in easily understood language
    Chronic central serous chorioretinopathy
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    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 No
    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 chronic CSC patients with subretinal fluid on optical coherence tomography (OCT) scanning achieving an absence of this subretinal fluid on OCT as compared to HSML treatment.
    E.2.2Secondary objectives of the trial
    To investigate the clinical outcome comparing half-dose PDT treatment with HSML treatment in patients with subretinal fluid due to active leakage in chronic CSC, based on evaluation of best-corrected visual acuity, retinal sensitivity on microperimetry, and subjective success score on the NEI VFQ-25 questionnaire of visual functioning
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • male and female patients ≥ 18 years of age who are able to give written informed consent
    • active chronic central serous chorioretinopathy
    • decline in best-corrected visual acuity/BCVA (< 20/20 Snellen equivalent) associated with subjective visual loss > 6 weeks, interpreted as onset of active disease
    • subretinal fluid that includes the fovea on OCT scanning at Baseline Examination.
    PLEASE NOTE: Subretinal fluid does not have to include fovea on OCT to be eligible for treatment at Control Visit 1, as long as there is persistent subretinal fluid in the macula, which is interpreted as persistently active disease (see 5.7 “Retreatment criteria and considerations”).
    • hyperfluorescent areas on ICG angiography
    • ≥1 ill-defined hyperfluorescent leakage areas on fluorescein angiography with retinal pigment epithelial window defect(s) that are compatible with chronic CSC
    E.4Principal exclusion criteria
    • any previous treatments for active CSC in the study eye
    • current treatment with corticosteroids (topical or systemic), or anticipated start of corticosteroid treatment within the first 7-8 months from the start of the trial period
    • evidence of other diagnosis that can explain serous subretinal fluid 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 ICG angiography
    • intraretinal edema on OCT
    • (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 eligibility screening
    • (relative) contraindications for fluorescein angiography or ICG angiography (known allergies especially against shellfish, previous reactions)
    • Soft drusen in treated eye or fellow eye, signs of choroidal neovascularization on ophthalmoscopy and/or fluorescein angiography/indocyanine green angiography
    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 the efficacy of half-dose PDT treatment versus HSML treatment in patients with chronic CSC.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The assessment of this efficacy will be based on the anatomical effect on optical coherence tomography (OCT): absence of subretinal fluid versus persistent subretinal fluid, 6-8 weeks after treatment.
    E.5.2Secondary end point(s)
    The secondary endpoints that will be assessed as a reflection of functional improvement after treatment include:
    - Number of second treatments needed in each treatment arm
    - Mean change from baseline in ETDRS BCVA in the study eye at 6-8 weeks after Treatment Visit 1 and at 7-8 months after Treatment Visit 1, among the two treatment modalities
    - Mean change from Evaluation Visit 1 in ETDRS BCVA in the study eye at final evaluation (7-8 months after Treatment Visit 1), among those who required one treatment and those who required a second treatment, and among the two treatment modalities overall
    - Mean change from baseline in retinal sensitivity on microperimetry in the study eye at 6-8 weeks after Treatment Visit 1 and at 7-8 months after Treatment Visit 1 among the two treatment modalities
    - Mean change from baseline in the NEI VFQ-25 questionnaire at 6-8 weeks after Treatment Visit 1 and at 7-8 months after Treatment Visit 1 among the two treatment modalities
    - An absence of subretinal fluid on evaluation with OCT scanning as compared to HSML treatment at 7-8 months follow-up after successful treatment (after Treatment Visit 1; “success” defined as an absence of subretinal fluid on OCT at 6-8 weeks after treatment)
    E.5.2.1Timepoint(s) of evaluation of this end point
    As secondary endpoints, we will mainly look at three parameters that reflect the patient’s vision-related functioning. These three parameters are: a standardized measurement of best-corrected visual acuity (BCVA) according to the Early Treatment of Diabetic Retinopathy Study (ETDRS) standards, a standardized measurement of sensitivity of the macula with microperimetry, and standardized assessment of the patient’s vision-related quality of life using a validated questionnaire, the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25).
    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 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 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 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 Yes
    E.8.2.3.1Comparator description
    high-density subthreshold micropulse laser
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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
    The end of trial is the date on which the last included participant has received the last follow-up visist (7-8 months after treatment 1)
    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 months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 140
    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)
    After the end of the study (follow-up visit 7-8 months after the first treatment visit), a new treatment may be considered, its details being left to the discretion of the treating ophtalmologist.
    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 Decision2014-07-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-05-30
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