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    Summary
    EudraCT Number:2006-006358-86
    Sponsor's Protocol Code Number:ATG003-201
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2007-03-02
    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 number2006-006358-86
    A.3Full title of the trial
    A PHASE II RANDOMIZED, DOUBLE-MASKED, STUDY COMPARING THE SAFETY AND EFFICACY OF ATG003 (MECAMYLAMINE HCL) 1.0% and 0.3% OPHTHALMIC SOLUTIONS TO PLACEBO IN PATIENTS WITH NEOVASCULAR ("WET") AGE-RELATED MACULAR DEGENERATION (NV-AMD)
    A.4.1Sponsor's protocol code numberATG003-201
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCoMentis, Inc., USA
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 No
    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 nameMecamylamine HCl
    D.3.2Product code ATG003
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMECAMYLAMINE HYDROCHLORIDE
    D.3.9.1CAS number 826391
    D.3.9.2Current sponsor codeATG003
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 No
    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 nameMecamylamine HCl
    D.3.2Product code ATG003
    D.3.4Pharmaceutical form Eye drops, solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOphthalmic use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMECAMYLAMINE HYDROCHLORIDE
    D.3.9.1CAS number 826391
    D.3.9.2Current sponsor codeATG003
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboEye drops, solution
    D.8.4Route of administration of the placeboOphthalmic use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Neovascular ("wet") Age-related Macular Degeneration (NV- AMD)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10064930
    E.1.2Term Age-related macular degeneration
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The objectives of this study are to establish the safety of ATG003 and to determine preliminary efficacy of two doses of ATG003 compared to placebo. The primary objective is to compare the change in visual acuity from baseline to week 48 between the patients treated with ATG003 to those treated with placebo - the proportion of patients losing fewer than 15 ETDRS letters (3 lines) of visual acuity in the study eye, using a standardized refraction and testing protocol at a starting test distance of 4 meters.
    E.2.2Secondary objectives of the trial
    To confirm the safety of ATG003 when given as twice daily eye drops for 48 weeks: proportion of patients losing fewer than 15 ETDRS letters of visual acuity in the study eye at 24 weeks compared to baseline; time to a loss of 15 ETDRS letters; mean change in VA over time from baseline; proportion of patients gaining 15 or more letters; the time to a gain of 15 ETDRS letters of VA in the study eye; proportion of patients with a Snellen equivalent of 20/200 or worse.
    Other secondary objectives include measures of anatomical changes to the retina: proportion of patients that have stable or reduced CNV lesion size; proportion of patients that have a 30% reduction in excess foveal thickness and/or subretinal fluid by OCT; mean and median change in excess foveal thickness and/or subfoveal fluid by OCT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Be males or females aged 50 years or older.
    Have subfoveal choroidal neovascularization (CNV) secondary to AMD of any angiographic subtype (classic, minimally classic, or occult with no classic).
    Have active CNV (which can include both classic and occult component) in the study eye which comprises at least 50% of the total area of the lesion (including blood,atrophy and scar).
    Have center point retinal thickness as measured by OCT of at least 275 microns due to subretinal and/or intraretinal fluid in the study eye
    Have best-corrected visual acuity using ETDRS charts of 20/40 to 20/400 (Snellen equivalent) in the study eye.
    Provide written informed consent
    Be able to comply with all study procedures and return for all study visits.
    E.4Principal exclusion criteria
    Scarring or atrophy of the fovea, or comprising > 25% of the total lesion area.
    Subretinal hemorrhage that involves the fovea, and if the size of the hemorrhage is either 50% or more of the total lesion area, or >1 disc areas in size.
    Retinal pigment epithelial tear involving the macula.
    Diabetic Retinopathy.
    Vitreous hemorrhage.
    Intraocular pressure of >30 mmHg despite treatment with anti-glaucoma medications
    Presence of significant ocular abnormalities that prevent retinal assessment, including media opacities (for example, cataract) and inadequate pupillary dilation, Likelihood that they will require cataract surgery in the study eye within the following year.
    Narrow angle glaucoma, diabetic retinopathy, retinal vascular occlusion, epiretinal membrane, or other conditions that are likely to significantly affect visual acuity during the study period.
    Presence of other causes of CNV including pathologic myopia (spherical equivalent of 8 diopters or more, or axial length of > 25mm), histoplasmosis syndrome, trauma, angioid streaks, choroidal rupture, or multifocal choroiditis
    History of any intraocular surgery (including cataract surgery) within 3 months of study entry.
    The following treatments for AMD within the previous six months including thermal laser, anti-VEGF therapy, intraocular or intravitreal corticosteroids, verteporfin photodynamic therapy, external- beam radiation therapy (in the region of the study eye), transpupillary thermotherapy, or any experimental therapies.Intraocular inflammation or periocular infection.
    History of allergy to fluorescein, not amenable to treatment with diphenhydramine.
    History of clinically significant renal disease or significant liver abnormality.
    Presence of any other concomitant medical condition that would adversely affect the patient’s ability to complete the study, or that might affect interpretation of the results of the study
    Any treatment with an investigational agent in the past 12 weeks for any condition
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of patients losing fewer than 15 ETDRS letters (3 lines) of visual acuity in the study eye assessed at 48 weeks compared to baseline using a standardized refraction and testing protocol at a starting test distance of 4 meters.
    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 Yes
    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) No
    E.8.2.2Placebo Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 350
    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)
    described in the protocol
    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 Decision2007-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-04-12
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2009-06-02
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