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    Summary
    EudraCT Number:2005-001235-30
    Sponsor's Protocol Code Number:MSI-1256F-302
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-09-19
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2005-001235-30
    A.3Full title of the trial
    A Phase 3 Multicenter, Randomized, Double-Masked, Controlled Study of Squalamine Lactate (MSI-1256F) for Injection for the Treatment of Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration
    A.4.1Sponsor's protocol code numberMSI-1256F-302
    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 SponsorGenaera Corporation
    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 Information not present in EudraCT
    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 nameSqualamine Lactate for Injection
    D.3.2Product code MSI-1256F
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSqualamine lactate for Injection
    D.3.9.1CAS number 148717-90-2
    D.3.9.2Current sponsor codeMSI-1256F
    D.3.9.3Other descriptive nameEvizon
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeThe white to off-white powder form will be provided as a sterile, lyophilized dosage suitable for reconstitution and further dilution for intravenous administration with 5% Dextrose Injection, USP.
    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
    Subfoveal Choroidal Neovascularization Associated with Age-Related Macular Degeneration
    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
    To evaluate the safety and efficacy of two doses (40 mg and 20mg) of Squalamine Lactate for Injection administered as intravenous infusions weekly for 4 weeks followed by maintenance doses every 4 weeks through week 104, compared with the safety and efficacy in the control group
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Must be considered reliable, willing and able to give informed consent.
    2.Must be ≥50 years of age, male or female.
    3.Must have subfoveal choroidal neovascularization (CNV) lesions associated with age-related macular degeneration (AMD) confirmed on fluorescein angiography in the study eye as predominantly classic, minimally classic or active occult.
    4.Active occult lesion must have presumed evidence of disease progression, defined as: deterioration of best-corrected visual acuity (BCVA) by ≥1 line Snellen (≥5 letters on the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol) within the past 3 months due to progression of CNV (not due to new onset CNV ), and one or more of the following —
    a.presence of subretinal/intraretinal blood;
    b.presence of subretinal/intraretinal fluid causing an increase in retinal thickness ≥250 microns confirmed by optical coherence tomography (OCT);
    c.growth of the lesion on fluorescein angiogram by ≥10% within the past 3 months.
    5.The following additional criteria must also be met regardless of lesion type —
    a.lesion diameter ≤12 disc areas including all lesion components: CNV, blood, blocked fluorescence from lipid, fibrosis, pigment, or hypofluorescence from serous pigment epithelial detachment (PED);
    b.CNV under the geometric center of the foveal avascular zone;
    c.area of fibrosis <25% of the area of the lesion;
    d.area of subretinal blood <50% of the area of the lesion;
    6.BCVA score must be between 64 to 24 letters on the ETDRS protocol
    7. Subject must be an acceptable candidate for fundus photography and angiography —
    a.the eye must be able to be photographed resulting in images of sufficient quality such that the macular area can be assessed;
    b.pupil size must be ≥5 mm after dilatation for the study eye
    8.Must have adequate organ function defined as
    a.marrow: white blood cells (WBC) ≥3000/mm3 (granulocytes ≥1500/mm3), platelets ≥100,000/mm3; hemoglobin (Hgb) ≥ 9 g/dL;
    b. hepatic: bilirubin ≤1.5 mg/dL, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and alkaline phosphatase ≤2x the upper limit of normal (ULN), and no hepatitis;
    c. renal: creatinine ≤1.5 mg/dL or calculated creatinine clearance ≥60 mL/min;
    d. heart: adequately controlled ventricular ectopy, chronic atrial fibrillation with controlled ventricular response, or clinically stable rate controlled atrial fibrillation.
    9. Women must be post-menopausal ≥1 year or surgically sterilized (negative serum pregnancy test required within 14 days prior to randomization);
    10. Men must agree to use barrier contraception or abstinence throughout the study or be surgically sterilized.
    11. BCVA or visualization of the macula must not be significantly impeded by cataracts or other media opacities.
    E.4Principal exclusion criteria
    1Previous laser photocoagulation therapy for “wet” AMD in the study eye (previous non-foveal photocoagulation and no more than one prior photodynamic therapy [PDT] with verteporfin are allowed).
    2.PDT with verteporfin in the study eye within 3 months prior to entering the study.
    3.Ocular surgery within the past 3 months for the study eye.
    4.Refractive eye surgery within the past 3 months for the study eye
    5.Glaucoma with visual field loss in the study eye (glaucoma and treatment in the fellow eye is acceptable).
    6.Intraocular pressure ≥ 25 mmHg (off or on medication) in the study eye.
    7.History of uveitis in the study eye.
    8.Ongoing infection of any sort in either eye at Baseline.
    9.Retinal or optic nerve disease that could independently affect visual acuity, including high axial myopia (>-8.00 diopters) or any diabetic retinopathy in the study eye.
    10.Anterior segment and vitreous abnormalities that would preclude adequate observation of the fundus for photographs, fluorescein angiography and OCT in the study eye.
    11.Use of investigational therapy within 30 days prior to Baseline.
    12.Previous treatment with Squalamine Lactate for Injection.
    13.Documented uncontrolled diabetes mellitus (best fasting plasma glucose >200 mg/dL in non-insulin dependent diabetes mellitus or >130 mg/dL in insulin-dependent diabetes mellitus).
    14.Clinically uncontrolled malignancy (stable disease for 5 years is allowed).
    15.Acute atrial fibrillation; recent myocardial infarction (<6 months); unstable angina; poorly controlled congestive heart failure; greater than first degree atrioventricular block; and clinically significant atrial or ventricular arrhythmias.
    16.A systemic or mental health condition that the investigator considers to be a reason for exclusion.
    17.Allergy to fluorescein dye, ICG dye, or iodine.
    18.Use of systemic or topical medications known to be toxic to the retina, lens, or optic nerve, eg, deferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, and ethambutol (see Study Reference Manual for complete list).
    19.Use of intravitreal or periocular injectable agents, including steroids, in the study eye.
    20.Use of high dose systemic steroids (>10mg prednisone or equivalent /day) within the past 6 months.
    21.Use of topical steroids in the study eye within the past 1 month.
    22.Use of any antiangiogenic compound locally or systemically (eg, thalidomide, bevacizumab (Avastin®) - see Study Reference Manual for complete list).
    E.5 End points
    E.5.1Primary end point(s)
    Loss in BCVA of ≥ 15 letters (ETDRS) at 52 weeks in the study eye compared to baseline.

    Secondary endpoints are as follows:
    1. Loss in BCVA of ≥15 letters (ETDRS) at 104 weeks in the study eye compared to baseline.
    2. Gain in BCVA of ≥15 letters (ETDRS) at 52 and 104 weeks in the study eye compared to baseline.
    3. Loss in BCVA of ≥15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with “wet” AMD (ie, subfoveal CNV lesions due to AMD confirmed on fluorescein angiography as predominantly classic, minimally classic or active occult).
    4. Gain in BCVA of ≥15 letters (ETDRS) at 52 and 104 weeks in the fellow eye compared to baseline in the subgroup of subjects whose fellow eye is affected with wet AMD.
    5. Loss in binocular visual acuity of ≥15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol.
    6. Gain in binocular visual acuity of ≥15 letters at 52 and 104 weeks compared to baseline, using a modified ETDRS protocol.
    7. Change in visual functioning and health-related quality of life at 52 and 104 weeks compared to baseline, as measured by the National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25).
    8. Change in retinal thickness (Bruch’s membrane to inner limiting membrane [ILM]) in the study eye at 52 and 104 weeks compared to baseline, as measured by OCT, in a subset of subjects.
    9. Change in area of CNV in the study eye at 52 and 104 weeks compared to baseline, as measured by fluorescein angiography.
    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 Information not present in EudraCT
    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) Yes
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Active product is diluted in 5% Dextrose Injection, USP; control is Dextrose Injection, USP
    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.8.5The trial involves multiple Member States Yes
    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 Information not present in EudraCT
    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 years2
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state71
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 533
    F.4.2.2In the whole clinical trial 650
    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 Decision2005-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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