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    Summary
    EudraCT Number:2005-001856-19
    Sponsor's Protocol Code Number:MRVT-920101-OPH005
    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:2005-09-09
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2005-001856-19
    A.3Full title of the trial
    A Phase III Randomized, Multicenter, Multinational, Double-Masked,
    Placebo-Controlled Study of Photrex™ (Rostaporfin) Photodynamic
    Therapy in the Treatment of Classic and Occult Subfoveal Choroidal
    Neovascularization Associated with Age-Related Macular Degeneration
    A.4.1Sponsor's protocol code numberMRVT-920101-OPH005
    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 SponsorMiravant Pharmaceuticals, Inc.
    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 namePhotrex (Rostaporfin)
    D.3.2Product code SnET2
    D.3.4Pharmaceutical form Emulsion for infusion
    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 INNRostaporfin
    D.3.9.1CAS number 284041-10-7
    D.3.9.3Other descriptive nameTin ethyl etiopurpurin (SnET2)
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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 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 Information not present in EudraCT
    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 placeboEmulsion for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
    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 confirm the efficacy and safety of rostaporfin (Photrex™; formerly known as SnET2) photodynamic therapy (PDT) in the treatment of classic and occult subfoveal choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD).
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Males and females, 50 years of age or older

    2. Able to understand and give written informed consent prior to performing any study related procedures.

    3. CNV consistent with AMD in study eye.

    4. At screening the active CNV lesions in the study eye:

    • Must have at least one subfoveal CNV membrane secondary to AMD that can be clearly demonstrated by FA.

    • Area of lesion components must not exceed 3 DA. Here, lesion components are defined as CNV plus adjacent blocked fluorescence and blood that may obscure underlying CNV. Furthermore, subretinal fibrous tissue is considered a lesion component. Determination of lesion size and composition will be
    made by the Fundus Photograph Reading Center (FPRC), Madison, WI.

    • Must not be developing an early disciform scar that is greater than 25% of the
    area of the lesion as judged from clinical examination and/or color
    photographs (as determined by the FPRC, Madison, WI).

    In each subject only one lesion in one study eye may be treated with rostaporfin-
    PDT. Selection of the study eye is at the discretion of the investigator.

    5. At screening the purely occult CNV lesions in the study eye must exhibit evidence of SSRD or PED, with the size of SSRD or PED being at least 2 DA (as determined by
    the FPRC, Madison, WI).

    6. Must have a best-corrected Screening visual acuity score of 34 – 70 ETDRS (Early TreatmentDiabetic Retinopathy Study) letters (Snellen-equivalent approximately 20/200 to 20/40).
    E.4Principal exclusion criteria
    1. Previous laser treatment for subfoveal macular disease in the study eye.

    2. Anterior segment abnormalities including those of the cornea, anterior chamber, iris, or lens that would preclude adequate examination of the ocular fundus or obtaining good quality images. The pupil of the study eye cannot be dilated to ≥ 4 mm.

    3. Ocular surgery (excluding yttrium aluminum garnet [YAG] capsulotomy) in the study
    eye within the past three months.

    4. Glaucoma of any type, in the study eye, if the cup/disc ratio is ≥ 0.8 or if field loss is advanced (≥ 10 decibel decrease in the automatic perimeter in the 30-degree central visual field).

    5. Ocular disease of any type in the study eye that could independently affect VA of the study eye, such as diabetic retinopathy (>10 microaneurysms or small retinal
    hemorrhages), high axial myopia (>-8.00 diopters), pattern dystrophy, epiretinal
    membranes, nevus associated with neovascular membrane, macular hole with or
    without neovascular membranes, nystagmus, branch vein occlusion or RPE
    abnormalities other than AMD.

    6. Dense submacular hemorrhage ≥ 50% of study lesion area (a pseudopod of blood
    extending from the lesion that is so narrow as to be unlikely to obscure underlying
    CNV is excluded when determining lesion area).

    7. CNV from other disease, i.e., high myopia (axial length >8 diopters), angioid streaks, pseudoxanthoma elasticum, presumed ocular histoplasmosis or idiopathic CNV.

    8. Pigmentation of the macular or paramacular region from the prior use of any maculaaffecting drugs such as hydroxychloroquine, chloroquine, thioridazine, other
    phenothiazine derivatives, or any use of these drugs within the last 12 months.

    9. Use of an investigational drug or other investigational therapy within 30 days prior to study drug dosing.

    10. Intravitreal injections administered in the study eye within 6 months prior to study entry.

    11. Use of any systemic or topical PDT agents.

    12. Use of Thalidomide for treatment of AMD or other diseases.

    13. Known allergic or hypersensitivity reactions to light, fluorescein, egg proteins, or eggyolk.

    14. History of porphyria, systemic lupus erythematosus, or xeroderma pigmentosum.

    15. Known disorder of lipoprotein metabolism or clearance (cholesterol> 400 mg/dl,
    and/or triglycerides > 500 mg/dl).

    16. Gamma glutamyl transferase (GGT) at study entry ≥ 2.5 times upper limit of normal.

    17. Compromised hepatic function within 14 days of therapy (i.e., bilirubin >1.5 times
    the upper limit of normal, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) or alkaline phosphatase > 2.5 times the upper limit of normal levels).

    18. Compromised cardiovascular function (i.e., myocardial infarction (MI) within the
    past 6 months, clinically significant arrhythmia, or clinically significant conduction
    abnormalities).

    19. Presence of significant coronary artery disease that requires ongoing coumarin
    anticoagulants therapy, which include warfarin and dicumarol. (Aspirin antithrombotic therapy will not exclude subjects.)

    20. Significant pulmonary insufficiency reported within the last 12 weeks.

    21. The presence of any disease that would make survival for the study period unlikely or that severely limits the study subjects’s daily activity, or is likely to limit activity within 2 years, to the extent that the study subjects would be unable to return for regular follow-up visits.

    22. Pregnancy or a positive urine pregnancy test result within 7 days of treatment, or
    nursing (only women of childbearing potential).

    23. Antabuse® (disulfiram) therapy within the last two weeks.

    24. Any condition, in the investigator’s opinion that places the subject at undue risk by participating in the study.

    25. Previous enrollment in this study.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy variable will be the proportion of subjects losing fewer than 15 letters (<3 lines of visual acuity loss) compared to baseline, as measured on an ETDRS chart. This efficacy variable will be examined at two time points, 51 weeks and 103 weeks after the start of treatment. Demonstration of statistically significant benefit at the Week 51 endpoint will satisfy the efficacy requirements for market approval. If significant benefit is not demonstrated at Week 51 , the success rate at Week 103 will be tested and, if significance is demonstrated, this data set will satisfy the efficacy requirements for approval.
    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 No
    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 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 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 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.8.5The 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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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 months8
    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 months8
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2005-09-09. Yes
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 240
    F.4.2.2In the whole clinical trial 660
    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 Decision2005-10-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-08-25
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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