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    Summary
    EudraCT Number:2004-004867-31
    Sponsor's Protocol Code Number:EOP 1012
    National Competent Authority:Austria - BASG
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2005-04-19
    Trial results View 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 ConcernedAustria - BASG
    A.2EudraCT number2004-004867-31
    A.3Full title of the trial
    A phase 3B, randomised, active controlled, double-masked, single dummy, multi-center comparative trial, in parallel groups, to compare the safety and efficacy of intravitreous injections of Macugen™ given every 6 weeks for 54 weeks (to be extended to 102 weeks as indicated) plus sham photodynamic therapy (PDT), to Macugen™ plus PDT with Visudyne®, in subjects with predominantly classic subfoveal chorodial neovascularization (CNV) secondary to age-related macular degeneration (AMD).
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberEOP 1012
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorEyetech 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.2.1.1.1Trade name Macugen
    D.2.1.1.2Name of the Marketing Authorisation holderEyetech Pharmaceuticals Inc.
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameMacugen
    D.3.2Product code EYE001
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPegaptanib Sodium
    D.3.9.2Current sponsor codeEYE001
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.3mg
    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 No
    D.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Visudyne 15mg, powder for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharma Ltd
    D.2.1.2Country which granted the Marketing AuthorisationAustria
    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 nameVisudyne
    D.3.4Pharmaceutical form Powder for solution 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 INNVerteporfin
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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 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
    Exudative 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
    Results from a limited number of subjects suggest that enhanced efficacy may be possible by combining PDT with Visudyne® with a VEGF inhibitor, such as Macugen™. The objective of this trial is to compare the safety and efficacy (best corrected ETDRS visual acuity) of Macugen™ when given as intravitreous injections of 0.3mg/eye every 6 weeks plus sham PDT to the same regimen of Macugen™ plus PDT with Visudyne® if indicated, as often as every 12 weeks based on the presence of CNV leakage as indicated in the label, in subjects with predominantly classic subfoveal chlorodial neovascularization (CNV) secondary to AMD. Primary endpoint to be assessed at 54 weeks. Trial to be extended to 102 weeks if primary endpoint is met with statistical significance at week 54 (p < 0.05 or = 0.05). Overall health status and vision-related functional status will be measured using standardized subject reported outcomes questionnaires.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Ophthalmic Criteria
    1. Subfoveal choroidal neovascularization (CNV) due to AMD.
    2. Predominantly classic lesion composition.
    3. Best corrected visual acuity in the study eye between 20/40 and 20/200, and better or equal to 20/800 in the fellow eye.
    4. The greatest linear dimension of the lesion (including blood, neovascularization, and scar/atrophy) must be >5,400 microns and the most nasal part of the lesion must be at least 200 microns from the temporal edge of the optic disc. At least 50% of the total lesion size must be CNV (classic CNV plus any occult CNV).
    5. The total area of any lesion components other than CNV, such as subretinal hemorrhage must comprise less than 50% of total lesion size.
    6. Clear ocular media and adequate pupillary dilatation to permit good quality stereoscopic fundus photography.
    7. Intraocular pressure (IOP) of 21mmHg or less.

    General Criteria
    1. Subjects of either gender, aged at least 50 years.
    2. Performance Status of at least 2 according to Eastern Cooperative Oncology Group (ECOG) / World Health Organization (WHO) scale.
    3. Normal electrocardiogram (ECG) or clinically non-significant changes.
    4. Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a serum pregnancy test must be performed within 14 days prior to the first injection with a negative result. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
    5. Adequate haematological function: haemoglobin equal to or more than 10g/dL; platelet count equal to or more than 130 x 10exp9/L; WBC equal to or more than 3.8 x 10exp9/L.
    6. Adequate renal function: serum creatinine less 2.5 mg/dl and BUN within 2 x the upper limit of normal (ULN).
    7. Adequate liver function: serum bilirubin less than or equal 1.5 mg/dl, GGT, SGOT/ALT, SGPT/AST, and alkaline phosphatase within 2 x ULN.
    8. Provide written informed consent.
    9. Ability to return for all trial visits.
    E.4Principal exclusion criteria
    Subjects will not be eligible for the trial if patients cannot attend all study required visits, or if any of the following criteria are present systemically or in the study eye:
    1. Previous subfoveal and non foveal thermal laser therapy.
    2. Any prior PDT with Visudyne to the study eye.
    3. More than 25% of the total lesion size made up of scarring or atrophy. Subjects with subfoveal scar or subfoveal atrophy are excluded.
    4. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity, or fundus photography. Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years.
    5. Presence of other causes of choroidal neovascularixzation, including pathologic myopia (spherical equivalent of –8 diopters or more negative, or axial length of 25mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
    6. Any intraocular surgery or thermal laser to the study eye within 3 months of trial entry.
    7. Any ocular or peri-ocular infection in the past 4 weeks.
    8. Previous posterior vitrectomy.
    9. Previous or concomitant therapy with intravitreous corticosteroids.
    10. Previous or concomitant therapy with another investigational agent to treat AMD, except oral supplements of vitamins and minerals.
    11. Presence of pigment epithelia tears or rips.
    12. Any of the following underlying diseases including:
    - Diabetic retinopathy
    - History or evidence of severe cardiac disease (e.g. NYHA Functional Class III or IV) clinical or medical history of unstable angina, actute coronary syndrome, myocardial infarction or revascularization with 6 months, ventricular tachyarrythmias requiring ongoing treatment.
    - History or evidence clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
    - Clinically significant impaired renal (serum creatinine >2.5mg/dl or s/p renal transplant or receiving dialysis) or hepatic function.
    - Stroke (within 12 months of trial entry).
    - Any major surgical procedure within one month of study entry.
    13. Previous therapeutic radiation in the region of the study eye.
    14. Any treatment with an investigational agent in the past 60 days for any condition.
    15. Known serious allergies to the fluorescein dye used in angiography,
    contraindications indicated in the product label for Visudyne® / PDT (porphyria), or to the components of Macugen™ formulation.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is vision at 54 weeks based on comparing the proportion of subjects having lost <15 letters of visual acuity.

    Secondary efficacy endpoints to be measured at 54 weeks include: The proportion of subjects gaining > 0. 5, 10 and 15 letters of visual acuity; proportion of subjects losing < 30 letters visual acuity; the number of PDT treatments required; and the mean change in visual acuity. The same endpoints will be measured at 102 weeks if statistical significance (p< 0.05) is achieved for the primary endpoint at 54 weeks.

    Other endpoints will include: changes in lesion size: progression of classic CNV; progression of occult CNV; changes in CNV size; retinal thickening (OCT); and changes in subjects reported vision-related functioning and preference scale (NEI VFQ-25 and SST VPVS).

    Outcome listed above also will be evaluated within subgroups stratified at baseline, except stratification by centre.

    Safety assessment will include all adverse changes from baseline (expect those related to disease progression) including laboratory changes.
    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 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 Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sham Photodynamic Therapy with 5% dextrose
    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
    54 weeks (to be extended to 102 weeks as indicated in protocol)
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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.1.3Elderly (>=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 2005-04-19. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 165
    F.4.2.2In the whole clinical trial 360
    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)
    As expected for normal treatment of this condition
    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 Decision2005-05-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-05-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2006-10-11
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