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    Summary
    EudraCT Number:2017-004409-42
    Sponsor's Protocol Code Number:LRP/LUBT010/2016/008
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-10-12
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2017-004409-42
    A.3Full title of the trial
    A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration
    Globális, III. fázisú, kettős vak, randomizált, kontrollált vizsgálat a LUBT010 készítmény hatásosságának, biztonságosságának és immunogenitásának Lucentis ® készítménnyel való összehasonlítására neovaszkuláris életkorral összefüggő makuladegenerációban szenvedő betegek esetében
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Global, Phase III, Double Blind, Randomized Controlled Study to Compare the Efficacy, Safety & Immunogenicity of LUBT010 with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration
    A.4.1Sponsor's protocol code numberLRP/LUBT010/2016/008
    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 SponsorLupin Limited (Biotechnology Division)
    B.1.3.4CountryIndia
    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 supportLupin Limited
    B.4.2CountryIndia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLupin Limited (Research Park)
    B.5.2Functional name of contact pointClinical Research Unit
    B.5.3 Address:
    B.5.3.1Street Address46A/47A, Nande
    B.5.3.2Town/ cityMulshi Pune
    B.5.3.3Post code412117
    B.5.3.4CountryIndia
    B.5.4Telephone number00912066749068
    B.5.6E-mailneelakantkrishnan@lupin.com
    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 nameRanibizumab
    D.3.2Product code LUBT010
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.2Current sponsor codeLUBT010
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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.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 Yes
    D.2.1.1.1Trade name Lucentis® 10 mg/ml solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNRANIBIZUMAB
    D.3.9.1CAS number 347396-82-1
    D.3.9.4EV Substance CodeSUB22314
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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
    Neovascular Age Related Macular Degeneration (AMD)
    E.1.1.1Medical condition in easily understood language
    Neovascular (Wet) Age Related Macular Degeneration (AMD)
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071129
    E.1.2Term Neovascular age-related macular degeneration
    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 demonstrate the equivalence in efficacy of LUBT010 to Lucentis® in terms of visual acuity, in patients with Neovascular Age-Related Macular Degeneration.
    E.2.2Secondary objectives of the trial
    - To assess the safety and tolerability of LUBT010 as compared to Lucentis®.
    - To assess the immunogenicity of LUBT010 as compared to Lucentis®
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Ambulatory male or female participants with age ≥ 50 years at the time of screening who are capable of understanding and giving written informed consent.
    2. Primary or recurrent (anti-VEGF naïve) active CNV@ lesions involving the foveal center secondary to AMD in any one of the eyes.
    3. BCVA in the study eye, using ETDRS testing, between 20/40 and 20/200 (Snellen equivalent), both inclusive, before pupil dilation.
    4. Willingness and ability to undertake all scheduled visits and assessments.
    5. Females, who are of non-child bearing potential (surgically sterile or menopausal), OR, if of child bearing potential using effective birth control measures and non-pregnant and non-lactating during the study and 3 months after the last dose(Refer Section 2 - Definition of Terms).
    @Active CNV is defined as any leakage detected on FA
    E.4Principal exclusion criteria
    -Known hypersensitivity to ranibizumab or any of the components of study medication.
    -Known history of allergy to fluorescein dye.
    -Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA (confirmed by independent central reading center).
    -Subretinal hemorrhage in the study eye that involves the center of the fovea, the size of the hemorrhage is either ≥ 50% of the total lesion area or ≥ 1-disc area in size (confirmed by independent central reading center).
    -Total lesion area ≥ 12.0-disc areas (DA) in size (including blood, scars, and neovascularization) as assessed by FA in the study eye (confirmed by independent central reading center).
    -History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye.
    -Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized.
    -Any other pathology involving the CNV lesion like retro-foveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50% of lesion area of study eye that can affect the efficacy of drug.
    -Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tears or rips involving the macula or macular hole (stage 1 to 4) in the study eye as assessed by FA (confirmed by independent central reading center).
    -Uncontrolled glaucoma as evident by progressive damage to optic nerve or visual fields despite optimum therapy; or steroid-induced glaucoma with continued use of steroids that requires IOP-lowering treatment.
    -History of serious complications following surgery in the study eye within 1 year prior to randomization.
    -Previous treatment with intravenous or intravitreal anti-VEGF agents such as Bevacizumab, Ranibizumab, Aflibercept, Pegaptanib, Brolucizumab in either of the eyes.
    -Previous external beam radiation or any laser therapy photocoagulation/ thermal laser thermotherapy/verteporfin photodynamic therapy (PDT) involving the foveal center in the study eye within 5 years prior to randomization.
    -Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy (except subfoveal) in the study eye or use of protein kinase C inhibitors within 3 months prior to randomization.
    -Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization.
    Previous treatment with intravitreal steroid implant (like Ozurdex®) within 6 months prior to randomization.
    -Concurrent use of systemic anti-VEGF agents.
    -Intraocular surgery (including cataract surgery) in the study eye within 3 months prior to randomization.
    -Concurrent treatment with an investigational drug or device in the non-study eye.
    -Previous participation in any studies of investigational drugs within 30 days or as prescribed in that study (whichever is later) preceding the initial study treatment.
    -Patients who have DME and/or background or proliferative retinopathy will be excluded. Likewise, any with significant posterior subcapsular cataract (PSC) should be excluded
    -CNV in the study eye due to causes other than AMD such as histoplasmosis, trauma, or pathological myopia etc. or CNV lesion not likely to respond to ranibizumab.
    -Active or ongoing ocular infection (e.g. infectious conjunctivitis, keratitis, scleritis, or endophthalmitis) or severe inflammation in either of the eyes.
    -Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 12 month study period or that could contribute to a loss (of at least 2 Snellen equivalent lines) of BCVA over the 12 months study period (e.g. progressive retinal disease or retinal pathology, cataract, glaucoma, uveitis, previous corneal transplant, the refractive error more than -8 diopters of myopia etc.). The decision regarding exclusion is to be based on the opinion of the Investigator.
    -Any patient with cloudy media from any cause that prevents adequate visualization of the fundus with indirect ophthalmoscopy should be excluded.
    -Patients with seropositivity for hepatitis B, hepatitis C, HIV antibody, syphilis tests or any immunodeficiency and/or immunosuppressive disease or active systemic infection.
    -History or presence of concurrent systemic diseases or dysfunctions requiring significant medical/ surgical intervention during study period that might affect interpretation of the results or contraindicates the use of ranibizumab or render the patient at high risk for treatment complications based on the Investigator’s judgment such as: Cardiovascular disease, uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine,
    immunologic, dermatologic, neurologic, metabolic, pulmonary, autoimmune disease or psychiatric disease based on previous
    history etc.
    E.5 End points
    E.5.1Primary end point(s)
    Mean change in BCVA from baseline in the study eye at the end of 12 months, assessed with the ETDRS chart.
    E.5.1.1Timepoint(s) of evaluation of this end point
    at the end of 12 months
    E.5.2Secondary end point(s)
    Efficacy
    • Mean change in BCVA from baseline in the study eye at the end of 3 months, assessed with the ETDRS chart.
    • Mean change in BCVA from baseline in the study eye at the end of 6 and 9 months, assessed with the ETDRS chart.

    Safety
    • Adverse Events (AE) assessment, ocular and non-ocular
    • Ophthalmic examination
    • Physical and systemic examination
    • Vital signs
    • Electrocardiogram (ECG)
    • Laboratory parameters - Blood (hematology and biochemistry) and urinalysis

    Immunogenicity
    Proportion of patients with anti-drug antibodies at the end of 1, 3, 6, 9, and 12 months.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Efficacy
    • Mean change in BCVA from baseline in the study eye at the end of 3 months, assessed with the ETDRS chart.
    • Mean change in BCVA from baseline in the study eye at the end of 6 and 9 months, assessed with the ETDRS chart.

    Safety
    • Adverse Events (AE) assessment, ocular and non-ocular
    • Ophthalmic examination
    • Physical and systemic examination
    • Vital signs
    • Electrocardiogram (ECG)
    • Laboratory parameters - Blood (hematology and biochemistry) and urinalysis

    Immunogenicity
    Proportion of patients with anti-drug antibodies at the end of 1, 3, 6, 9, and 12 months.
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenicity
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Lucentis® 10 mg/ml solution for injection
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Bulgaria
    Czech Republic
    Estonia
    Hungary
    India
    Latvia
    Poland
    Slovakia
    United States
    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
    LVLS
    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 months10
    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 months2
    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: 84
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 516
    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 state63
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 366
    F.4.2.2In the whole clinical trial 600
    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)
    None
    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 Decision2020-11-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-03-09
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