check_circleStudy Completed

Retinal Vein Occlusion

Bayer Identifier:

14130

ClinicalTrials.gov Identifier:

NCT01012973

EudraCT Number:

2009-010973-19

EU CT Number:

Not Available
Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Central Retinal Vein Occlusion (CRVO)

Trial purpose

To determine the efficacy of vascular endothelial growth factor (VEGF) Trap-Eye injected into the eye on vision function in subjects with macular edema as a consequence of central retinal vein occlusion

Key Participants Requirements

Sex

Both

Age

18 Years
  • - Center-involved macular edema secondary to central retinal vein occlusion (CRVO) for no longer than 9 months with mean central subfield thickness ≥ 250 μm on optical coherence tomography (OCT)
    - Adults ≥ 18 years
    - Early treatment diabetic retinopathy study (ETDRS) best corrected visual acuity (BCVA) of 20/40 to 20/320 (73 to 24 letters) in the study eye
  • - Any prior treatment with anti-VEGF agents in the study eye (Pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or previous administration of systemic anti-angiogenic medications
    - Prior panretinal laser photocoagulation or macular laser photocoagulation in the study eye
    - CRVO disease duration > 9 months from date of diagnosis
    - Previous use of intraocular corticosteroids in the study eye or use of periocular corticosteroids in the study eye within the 3 months prior to Day 1
    - Iris neovascularization, vitreous hemorrhage, traction retinal detachment, or preretinal fibrosis involving the macula in either the study eye or fellow eye

Trial summary

Enrollment Goal
177
Trial Dates
October 2009 - February 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Klinikum der Eberhard-Karls-Universität TübingenTübingen, 72076, Germany
Completed
Universitätsklinikum FreiburgFreiburg, 79106, Germany
Completed
Klinikum rechts der IsarMünchen, 81675, Germany
Completed
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Completed
Universitätsklinikum HeidelbergHeidelberg, 69120, Germany
Completed
Universitätsklinikum Schleswig-Holstein / AÖRLübeck, 23538, Germany
Completed
Klinikum DarmstadtDarmstadt, 64297, Germany
Completed
Klinikum der Stadt Ludwigshafen am Rhein gGmbHLudwigshafen, 67063, Germany
Completed
Universitätsklinikum AachenAachen, 52074, Germany
Completed
Klinikum Chemnitz gGmbHChemnitz, 09116, Germany
Terminated
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Universitätsklinikum Hamburg Eppendorf (UKE)Hamburg, 20251, Germany
Completed
Universitätskliniken des SaarlandesHomburg, 66421, Germany
Completed
Medizinische Einrichtungen der Universität BonnBonn, 53105, Germany
Completed
Klinikum der Christian-Albrechts-UniversitätKiel, 24105, Germany
Completed
Universitätsklinikum Leipzig AöRLeipzig, 04103, Germany
Terminated
Medizinische Fakultät Carl Gustav CarusDresden, 01307, Germany
Completed
Universitätsklinikum KölnKöln, 50924, Germany
Completed
Krankenhaus Dresden-FriedrichstadtDresden, 06067, Germany
Completed
Universitätsmedizin der Georg-August-Universität GöttingenGöttingen, 37075, Germany
Completed
Universitätsklinikum RegensburgRegensburg, 93053, Germany
Completed
Centre Ophthalmologie d'Imagerie et de LaserParis, 75015, France
Completed
Nagoya University HospitalNagoya, 466-8560, Japan
Completed
Kyoto University HospitalKyoto, 606-8507, Japan
Completed
A.O.U. Policlinico ConsorzialeBari, 70124, Italy
Completed
A.O.U. Ospedali Riuniti Umberto I - Lancisi - SalesiAncona, 60126, Italy
Completed
ASL RM/A Roma - LazioRoma, 00198, Italy
Completed
Universitätsklinik Gießen und Marburg GmbHMarburg, 35037, Germany
Completed
C.H.U. PellegrinBordeaux, 33000, France
Completed
Centre d'Ophtalmologie - Paradis-MonticelliMARSEILLE, 13008, France
Terminated
Centre Hospitalier National d'Ophthalmologie Quinze-VingtParis, 75557, France
Completed
Hôpital Hôtel Dieu - Nantes CedexNantes, 44093, France
Completed
Centre Hospitalier Universitaire de DijonDijon, 21033, France
Completed
Nagoya City University HospitalNagoya, 467-8602, Japan
Completed
Juntendo University Urayasu HospitalUrayasu, 279-0021, Japan
Completed
Surugadai Nihon University HospitalChiyoda-ku, 101-8309, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
A.O.U. Policlinico Tor VergataRoma, 00133, Italy
Completed
IRCCS Fondazione Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Terminated
A.O.U. PoliclinicoCatania, 95123, Italy
Terminated
A.O. di PadovaPadova, 35128, Italy
Terminated
A.O. Sacco Polo UniversitarioMilano, 20157, Italy
Terminated
ASL TO/2 - PiemonteTorino, 10122, Italy
Completed
Lion Eye InstituteNedlands, 6009, Australia
Completed
Vision Eye InstituteChatswood, 2067, Australia
Completed
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
University of SemmelweisBudapest, 1089, Hungary
Completed
Bajcsy Zsilinszky HospitalBudapest, 1106, Hungary
Completed
University of Debrecen Medical&Health Science CenterDebrecen, 4032, Hungary
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul St. Mary's HospitalSeoul, 137-701, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110 744, Korea, Republic Of
Completed
Yonsei University College of MedicineSeoul, Korea, Republic Of
Completed
National University HospitalSingapore, 119074, Singapore
Completed
Latvijas-Amerikas acu centrsRiga, 1050, Latvia
Completed
Paula Stradina Kliniskas Universitates slimnicaRiga, 1002, Latvia
Completed
Save Sight InstituteSydney, 2000, Australia
Completed
Marsden Eye Surgery CenterParramatta, 2150, Australia
Completed
Westmead HospitalWestmead, 2145, Australia
Completed
Centre for Eye ResearchEast Melbourne, 3002, Australia
Completed
Konventhospital Barmherzige Brüder LinzLinz, 4021, Austria
Terminated
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Completed
A.ö. Krankenhaus der Stadt LinzLinz, 4021, Austria
Terminated
Csolnoky Ferenc HospitalVeszprem, 8200, Hungary
Completed
Budapest Retina AssociatesBudapest, 1133, Hungary
Completed
Zala Megyei KorhazZalaegerszeg, H-8900, Hungary
Completed
Gachon University Gil Medical CenterIncheon, 405-760, Korea, Republic Of
Completed
Seoul National Univ. Bundang HospitalSeongnam-si, 463-707, Korea, Republic Of
Completed
Singapore National Eye CentreSingapore, 168751, Singapore
Terminated
Charité Campus Virchow-Klinikum (CVK)Berlin, 13353, Germany
Terminated
St. Franziskus-Hospital GmbHMünster, 48145, Germany
Completed
Klinikum der Johann Wolfgang Goethe Universität FrankfurtFrankfurt, 60596, Germany

Primary Outcome

  • Percentage of participants who gained at least 15 letters in BCVA as measured by ETDRS letter score compared with baseline at Week 24 with discontinued participants before Week 24 evaluated as failures
    date_rangeTime Frame:
    Baseline and Week 24
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Change from baseline in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score at Week 24 - Last observation carried forward (LOCF)
    date_rangeTime Frame:
    Baseline and Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in Central Retinal Thickness (CRT) at Week 24 - LOCF
    date_rangeTime Frame:
    Baseline and Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants who developed Neovascularization during the first 24 weeks
    date_rangeTime Frame:
    From baseline until Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in National Eye Institute 25-item Visual Function Questionnaire (NEI VFQ-25) total score at Week 24 - LOCF
    date_rangeTime Frame:
    Baseline and Week 24
    enhanced_encryption
    Safety Issue:
    No
  • Change from baseline in European five-dimensional health scale (EQ-5D) score at Week 24 - LOCF
    date_rangeTime Frame:
    Baseline and Week 24
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, double-masked, sham-controlled phase 3 study of the efficacy, safety and tolerability of repeated intravitreal administration of VEGF Trap-Eye in subjects with macular edema secondary to central retinal vein occlusion (CRVO)
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

Click here and search for drug information provided by the FDA.Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.Click here to find results for studies related to Bayer Healthcare products.Click here to find information about studies related to Bayer Healthcare products conducted in Europe