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    Summary
    EudraCT Number:2012-005439-10
    Sponsor's Protocol Code Number:RabOCT
    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:2013-07-23
    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 number2012-005439-10
    A.3Full title of the trial
    Re-treatment with intravitreal application of ranibizumab guided by morphological macular changes documented by optical coherence tomography (OCT) in patients with macular edema due to branch retinal vein occlusion
    Wiederbehandlung mit Ranibizumab bei Patienten mit Makulaödem infolge eines Venenastverschlusses nach morphologischen Netzhautveränderungen erhoben mittels optischer Kohärenztomographie (OCT)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Re-treatment with intravitreal application of ranibizumab guided by morphological macular changes documented by optical coherence tomography (OCT) in patients with macular edema due to branch retinal vein occlusion
    Wiederbehandlung mit Ranibizumab bei Patienten mit Makulaödem infolge eines Venenastverschlusses nach morphologischen Netzhautveränderungen erhoben mittels optischer Kohärenztomographie (OCT)
    A.4.1Sponsor's protocol code numberRabOCT
    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
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDepartment of Ophthalmology, Universtity of Leipzig
    B.5.2Functional name of contact pointCoordinating Investigator
    B.5.3 Address:
    B.5.3.1Street AddressLiebigstr. 14-16
    B.5.3.2Town/ cityLeipzig
    B.5.3.3Post code04103
    B.5.3.4CountryGermany
    B.5.4Telephone number034197 21 650
    B.5.5Fax number034197 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 Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    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 branch retinal vein occlusion (BRVO)
    Makulaödem bei Venenastverschluss
    E.1.1.1Medical condition in easily understood language
    macular edema secondary to branch retinal vein occlusion (BRVO)
    Makulaödem bei Venenastverschluss
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10054467
    E.1.2Term Macular edema
    E.1.2System Organ Class 100000004853
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10038906
    E.1.2Term Retinal vein branch occlusion
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is the efficacy endpoint which is the change of best corrected visual acuity (BCVA) measured in ETDRS letters.
    Das primäre Ziel ist der Wirksamkeitsendpunkt, welcher ist; die Veränderung der bestkorrigierten Sehschärfe in Buchstaben (geprüft mittels ETDRS Prüftafeln)
    E.2.2Secondary objectives of the trial
    • Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 52 (EoS).
    • Number of Ranibizumab injections applied per patients in total; maximally 11 injections may be applied based on standardized arm-specific retreatment criteria.
    • Rate of patients per group progressing to neovascularization of the retina or anterior segment which require pan-retinal photocoagulation.
    • Number of serious adverse events (SAEs)/ reactions (SARs – causally related to treatments) per group and
    • Number of adverse events (AEs)/ reactions (ARs) per group observed during the entire course of study.
    • Veränderung der zentralen Netzhautdicke (gemessen mittels Optischer Kohärenztomographie – OCT) zu Monat 12 im Vergleich zur Baseline.
    • Anzahl der benötigten Ranibizumab-Injektionen in beiden Studienarmen während der Studiendauer von 12 Monaten.
    • Anteil der Patienten, die Neovaskularisationen des Sehnervenkopfes, der Netzhaut, Regenbogenhaut (rubeosis iridis) oder ein Sekundärglaukom entwickeln. Die Prävalenz dieser Komplikationen wird zwischen den beiden Studienarmen verglichen.
    • Auswertung der Therapie-Sicherheit anhand der beobachteten unerwünschten Ereignissen (AEs) und
    • schwerwiegenden unerwünschten Ereignissen (SAEs).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Completed up-load phase of ranibizumab treatment (at least 3 monthly intravitreal injections) due to macular edema secondary to branch retinal vein occlusion with presence of recurrence of macular edema detected by optical coherence tomography (OCT) without decrease of BCVA score more than 3 ETDRS letters when compared with BCVA on day of 3rd ranibizumab application
    2. BCVA score in the study eye between 20 letters (20/400) and 78 letters (20/32) measured in ETDRS chart and foveal thickness ≥ 250 μm (measured by OCT) and prior to the first ranibizumab injection
    3. Age ≥ 18 years
    4. Written informed consent of the patient
    5. The history of BRVO no longer than 8 months prior to the first ranibizumab injection
    6. Ability and willingness to attend all scheduled visits and assessments
    1. Schriftliche Zustimmung der Teilnahme an der Studie
    2. Alter ≥ 18 Jahre
    3. Makulaödemrezidiv definiert als Vorhandensein jeglicher Flüssigkeit-Akkumulation in der Makula (Mikrozysten) mit oder ohne Zunahme der zentralen Netzhautdicke festgestellt mittels OCT ohne Verschlechterung der bestkorrigierten Sehschärfe (BCVA) im Zeitraum von max. 6 Monaten nach der dritten Ranibizumab-Injektion (abgeschlossener Upload Phase).
    4. Gesicherter Venenastverschluss, der mit mindestens 3 Applikationen von Ranibizumab behandelt wurde und die BCVA am Studienauge vor der ersten Ranibizumab-Applikation zwischen 20 Buchstaben (20/400) und 78 Buchstaben (20/32) betrug– gemessen mittels ETDRS-Prüftafeln
    5. Anamnese eines Venenastverschlusses vor der ersten Ranibizumab-Applikation, das nicht älter ist als 8 Monaten
    6. Bereitschaft an allen vorgeschrieben Studienvisiten teilzunehmen
    E.4Principal exclusion criteria
    1. Macular edema due to another etiology than retinal vein occlusion (e.g. diabetic maculopathy, uveitis, age related macular degeneration, Irvine-Gass syndrome)
    2. Evidence upon examination of vitreoretinal interface disease (e.g., vitreomacular traction, epiretinal membrane), either on clinical examination or OCT, thought to be contributing to macular edema
    3. 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
    4. Aphakia
    5. Macular laser photocoagulation in the study eye prior to study entry
    6. Use of intraocular or periocular injection of steroids in the study eye prior to study entry
    7. 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
    8. History of cerebral vascular accident, myocardial infarction, transient ischemic attacks in last 6 months prior to randomization
    9. The presence of active malignancy
    10. Pregnancy (positive pregnancy test) or lactation
    11. History of allergy to humanized antibodies or any component of the ranibizumab formulation
    12. Participation in another simultaneous medical investigation or trial
    13. 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.
    1. Makulaödem als Folge anderer Ursache (z.B. diabetische Retinopathie, altersabhängige Makuladegeneration, Irvine-Gass-Syndrom usw.)
    2. Vitreoretinale Traktion (gesichert mittels OCT), die zum Makulaödem beiträgt
    3. Netzhautveränderungen, die nach Ermessen des Prüfers nicht von der Resorption des Makulaödem profitieren würden (z.B. Makulaatrophie, dichte subfoveoläre Exsudate etc.)
    4. Aphakie
    5. Fokale zentrale Laserphotokoagulation der Makula in der Anamnese
    6. Anwendung der intra- oder periokulärer Steroidapplikation am Studienauge in der Anamnese
    7. Katarakt-Operation oder YAG-Laser-Kapsulotomie oder intraokularer Eingriff innerhalb von 3 Monaten vor dem Studieneinschluss
    8. Schlafanfall, transitorische ischämische Attacke oder Myokardinfarkt innerhalb von 6 Monaten vor dem Studieneinschluss
    9. Aktive maligne Erkrankung
    10. Schwangerschaft oder Stillen
    11. Bekannte Allergie auf Ranibizumab oder Fluoreszein
    12. Teilnahme an anderer klinischen Prüfung
    13. Frauen ohne angemessene Kontrazeption
    E.5 End points
    E.5.1Primary end point(s)
    Based on the BCVA assessment of the study eye - performed at all study visits and measured in ETDRS letters - the primary end point will be derived. For confirmatory analysis the change score in BCVA from within 12 months, i.e. end of study (EoS), will be calculated.
    Veränderung der bestkorrigierten Sehschärfe in Buchstaben (geprüft mittels ETDRS Prüftafeln) zu Monat 12 (Studienende) im Vergleich zur Baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of study for each patient
    Studieen für jeden Patienten
    E.5.2Secondary end point(s)
    • Change score in central retinal thickness (CRT), assessed by OCT between Week 1 and week 52 (EoS).
    • Number of Ranibizumab injections applied per patients in total; maximally 11 injections may be applied based on standardized arm-specific retreatment criteria.
    • Rate of patients per group progressing to neovascularization of the retina or anterior segment which require pan-retinal photocoagulation.
    • Number of serious adverse events (SAEs)/ reactions (SARs – causally related to treatments) per group and
    • Number of adverse events (AEs)/ reactions (ARs) per group observed during the entire course of study.
    • Veränderung der zentralen Netzhautdicke (gemessen mittels Optischer Kohärenztomographie – OCT) zu Monat 12 im Vergleich zur Baseline.
    • Anzahl der benötigten Ranibizumab-Injektionen in beiden Studienarmen während der Studiendauer von 12 Monaten.
    • Anteil der Patienten, die Neovaskularisationen des Sehnervenkopfes, der Netzhaut, Regenbogenhaut (rubeosis iridis) oder ein Sekundärglaukom entwickeln. Die Prävalenz dieser Komplikationen wird zwischen den beiden Studienarmen verglichen.
    • Auswertung der Therapie-Sicherheit anhand der beobachteten unerwünschten Ereignissen (AEs) und
    • schwerwiegenden unerwünschten Ereignissen (SAEs).
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of study for each patient
    Studieen für jeden Patienten
    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
    intravireale Injektionen von Ranibizumab gemäß Fachinformation
    intravitreal injection of ranibizumab according to the in SmPC
    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 No
    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 visit of the last subject
    Letzte Visite des letzten Patienten
    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 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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    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 state18
    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)
    After end of study, all patients will be further observed and treated at the Department of Ophthalmology University of Leipzig.
    Nach Studieende werden alle Patienten weiter beobachtet in der Klinik für Ophthalmologie an der Universität 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 Decision2013-08-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-05-17
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