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    Summary
    EudraCT Number:2010-020441-27
    Sponsor's Protocol Code Number:CORaLa
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-02-23
    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 ConcernedGermany - PEI
    A.2EudraCT number2010-020441-27
    A.3Full title of the trial
    Ranibizumab combined with selective peripheral laser photocoagulation for treatment of central retinal vein occlusion
    A randomized, controlled interventional phase 2b (proof of concept) study of of the efficacy, safety, and tolerability of repeated intravitreal administration of ranibizumab combined with selective laser photocoagulation of non-perfused retinal areas in subjects with macular edema secondary to central retinal vein occlusion (CRVO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ranibizumab combined with selective peripheral laser photocoagulation for treatment of central retinal vein occlusion
    A randomized, controlled interventional phase 2b (proof of concept) study of of the efficacy, safety, and tolerability of repeated intravitreal administration of ranibizumab combined with selective laser photocoagulation of non-perfused retinal areas in subjects with macular edema secondary to central retinal vein occlusion (CRVO)
    A.3.2Name or abbreviated title of the trial where available
    CORaLa
    A.4.1Sponsor's protocol code numberCORaLa
    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 SponsorUniversity of Leipzig Ritterstr. 26, 04109 Leipzig
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNovartis Pharma
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Leipzig
    B.5.2Functional name of contact pointPrincipal Investigator
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstrasse 10-14
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number0049034197 21 650
    B.5.5Fax number0049034197 21 659
    B.5.6E-mailaugen@medizin.uni-leipzig.de
    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 Yes
    D.2.1.1.1Trade name Lucentis (Ranibizumab)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical form 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.3.10 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) Yes
    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
    macular edema secondary to non-ischemic central retinal vein occlusion
    E.1.1.1Medical condition in easily understood language
    macular edema secondary to non-ischemic central retinal vein occlusion
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10054467
    E.1.2Term Macular edema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level LLT
    E.1.2Classification code 10007972
    E.1.2Term Central retinal vein occlusion
    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 evaluate the efficacy and safety of intraocular injections of ranibizumab in combination with selective laser photocoagulation of retinal areas of capillary non-perfusion
    E.2.2Secondary objectives of the trial
    • To evaluate the effects of the combined treatment regimen on central retinal thickness (CRT) measured by optical coherence tomography (OCT)
    • To evaluate the amount of required intravitreal applications of ranibizumab
    • To evaluate the proportion of patients progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularization of the retina elsewhere (NVE) requiring panretinal photocoagulation during the entire period of trial including the follow-up phase
    • To evaluate the safety of the combined treatment regimen with respect to the adverse and serious adverse events (AEs / SAEs)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Diagnosis of macular edema due to central retinal vein occlusion foveal thickness ≥ 250 μm (measured by OCT)
    2. Age > 18 years
    3. Written informed consent of the patient
    4. BCVA score in the study eye between 24 letters (20/320) and 73 letters (20/40) measured in ETDRS chart
    5. The history of CRVO no longer than 8 months
    6. Presence of capillary non-perfusion in peripheral retina larger than 1 and smaller than 10 disc areas documented in fluorescein angiography
    7. Ability and willingness to attend all scheduled visits and assessments
    E.4Principal exclusion criteria
    Ischemic CRVO defined as presence of capillary non-perfusion larger than 10 optic disc areas in fluorescein angiography
    2. Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
    3. Diagnosis of CRVO in both eyes with macular edema requiring any kind of treatment
    4. History of rhegmatogenous retinal detachment
    5. History of idiopathic central serous chorioretinopathy
    6. Presence of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or in OCT
    7. An eye that, in the investigator's opinion, would not benefit from resolution of macular edema, such as eyes with foveal atrophy, dense pigmentary changes, or dense subfoveal hard exudates
    8. Patients in which at time of screening the anti-VEGF treatment is planned for the fellow eye for any reason
    9. Aphakia
    10. Improvement of > 10 letters on BCVA between screening and Day 1
    11. Scatter laser photocoagulation or macular photocoagulation in the study eye prior to study entry
    12. Use of intraocular or periocular injection of steroids in the study eye prior to study entry
    13. Previous use of an anti-VEGF drug in the study eye
    14. Cataract surgery or Yttrium-Aluminum-Garnet (YAG) laser capsulotomy or any other intraocular surgery in the study eye within 3 months prior to study entry
    15. History or presence of AMD (dry or wet form)
    16. Uncontrolled glaucoma (defined as intraocular pressure ≥ 30 mm Hg despite treatment with anti-glaucoma medications)
    17. Uncontrolled blood pressure defined as pressure ≥ 160/90 mmHg in at least 3 consecutive measurements
    18. History of cerebral vascular accident
    19. Pregnancy (positive pregnancy test) or lactation
    20. The presence of active malignancy, including lymphoproliferative disorders.
    21. History of allergy to humanized antibodies or any component of the ranibizumab formulation
    22. Inability to comply with study procedures
    23. Participation in another simultaneous medical investigation or trial
    24. Ongoing drug abuse
    25. HIV positive
    26. Women with child bearing potency without effective contraception (i. e. implants, injectables, combined oral contraceptives, some IUDs or vasectomised partner) during the conduct of the trial.
    E.5 End points
    E.5.1Primary end point(s)
    To evaluate the efficacy of the combined treatment with respect to visual acuity, assessed by Best Corrected Visual Acuity (BCVA) of the study eye using the ETDRS chart
    E.5.1.1Timepoint(s) of evaluation of this end point
    After intervention phase Week 24 and after follow-up Week 52
    E.5.2Secondary end point(s)
     Change score in BCVA between Week 1 and last FU.
     Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 24 resp. last FU.
     Number of Ranibizumab injections applied per patients in total; as all patients will receive 3 intraocular injections a range from 3 to maximally 12 injections is expected guided by the visual acuity of patients and standardized retreatment criteria.
     Proportion of patients per group progressing to anterior segment neovascularization, neovascularization of the optic disc (NVD), or neovascularization of the retina elsewhere (NVE) requiring pan-retinal photocoagulation.
    Neovascularizations will be assessed at every visit and analyzed cumulatively per patient until week 24 resp. last FU.
     Number of serious adverse events (SAEs)/ reactions (SAR – causally related to treatments) per group and
     Number of adverse events (AEs)/ ARs per group observed during the entire course of study (including critical ocular events like abrupt, clinically significant decrease in BCVA, new onset of a clinically significant increase in intraocular pressure, corneal edema, intraocular inflammatory response etc).
    E.5.2.1Timepoint(s) of evaluation of this end point
    After intervention phase Week 24 and after follow-up Week 52
    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 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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
    additional laser photocoagulation
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    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 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
    Last patient last visit
    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 days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 22
    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)
    In case the patients will suffer under recurrence of macular edema with reduction of BCVA after the termination of the study, further treatment with anti-VEGF drugs (Ranibizumab or bevacizumab) or other treatment methods (e.g. application of triamcinolone acetonide, Dexamethasone implant = Ozurdex or vitrectomy) will be offered.
    After end of study, all patients will be further observed and treated at the Department of Ophthalmology University of Leipzig.
    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 Decision2011-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2012-09-25
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