Trial Condition(s):

Diabetes Mellitus, Macular Edema

Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID-DME)

Bayer Identifier:

91745

ClinicalTrials.gov Identifier:

NCT01331681

EudraCT Number:

2010-022364-12

Study Completed

Trial Purpose

To determine the efficacy of intravitreally (IVT) administered VEGF Trap-Eye on the best-corrected visual acuity (BCVA) assessed by the early treatment diabetic retinopathy study (ETDRS) chart in subjects with diabetic macular edema (DME) with central involvement

Inclusion Criteria
- Adults ≥ 18 years with type 1 or 2 diabetes mellitus
 - Subjects with DME secondary to diabetes mellitus involving the center of the macula in the study eye
 - Decrease in vision determined to be primarily the result of DME in the study eye
 - BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye
Exclusion Criteria
- Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1
 - More than 2 previous macular laser treatments in the study eye
 - Previous use of intraocular or periocular corticosteroids in the study eye within 120 days of Day 1
 - Previous treatment with antiangiogenic drugs in either eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Day 1
 - Active proliferative diabetic retinopathy (PDR) in the study eye, with the exception of inactive, regressed PDR
 - Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
 - Only 1 functional eye even if that eye is otherwise eligible for the study

Trial Summary

Enrollment Goal
406
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kiel, Germany, 24105

Status
Completed
 
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Investigative Site

Darmstadt, Germany, 64297

Status
Completed
 
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Investigative Site

Göttingen, Germany, 37075

Status
Completed
 
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Investigative Site

Freiburg, Germany, 79106

Status
Completed
 
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Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen, Germany, 67063

Status
Completed
 
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Investigative Site

Köln, Germany, 50924

Status
Completed
 
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Investigative Site

Bonn, Germany, 53105

Status
Completed
 
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Investigative Site

Tübingen, Germany, 72076

Status
Completed
 
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Investigative Site

München, Germany, 81675

Status
Completed
 
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Investigative Site

Aachen, Germany, 52074

Status
Completed
 
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Investigative Site

Heidelberg, Germany, 69120

Status
Completed
 
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Investigative Site

Paris, France, 75015

Status
Completed
 
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Investigative Site

Bordeaux, France, 33076

Status
Completed
 
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Investigative Site

Bytom, Poland, 41-902

Status
Completed
 
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Investigative Site

Padova, Italy, 35128

Status
Completed
 
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Investigative Site

Roma, Italy, 00198

Status
Completed
 
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Investigative Site

Ancona, Italy, 60126

Status
Completed
 
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IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Completed
 
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Investigative Site

Roma, Italy, 00133

Status
Completed
 
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Investigative Site

Santiago de Compostela, Spain, 15706

Status
Completed
 
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Investigative Site

Oviedo, Spain, 33012

Status
Completed
 
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Investigative Site

Valencia, Spain, 46015

Status
Completed
 
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Investigative Site

Ostrava, Czech Republic, 708 52

Status
Completed
 
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Investigative Site

Olomouc, Czech Republic, 77520

Status
Completed
 
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Faculty Hospital Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
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Investigative Site

Nedlands, Australia, 6009

Status
Completed
 
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Investigative Site

Parramatta, Australia, 2150

Status
Completed
 
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Investigative Site

East Melbourne, Australia, 3002

Status
Completed
 
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Sydney, Australia, 2000

Status
Completed
 
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Linz, Austria, 4021

Status
Completed
 
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Wien, Austria, 1090

Status
Completed
 
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Investigative Site

Linz, Austria, 4020

Status
Completed
 
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Hopital Lariboisiere

Paris, France, 75010

Status
Completed
 
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Investigative Site

Lyon, France, 69003

Status
Completed
 
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Investigative Site

Milano, Italy, 20157

Status
Completed
 
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Investigative Site

Århus C, Denmark, 8000

Status
Completed
 
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Investigative Site

Glostrup, Denmark, 2600

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 51-124

Status
Completed
 
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Investigative Site

San Cugat del Vallès, Spain, 08190

Status
Completed
 
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Alicante, Spain, 03016

Status
Completed
 
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Pamplona, Spain, 31008

Status
Completed
 
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Barcelona, Spain, 08036

Status
Completed
 
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Investigative Site

Mainz, Germany, 55131

Status
Completed
 
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Investigative Site

Asahikwa, Japan, 078-8510

Status
Completed
 
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Investigative Site

Sapporo, Japan, 060-8648

Status
Completed
 
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Investigative Site

Akita, Japan, 010-8543

Status
Completed
 
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Investigative Site

Sendai, Japan, 980-8574

Status
Completed
 
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Investigative Site

Shinjuku-ku, Japan, 162-8666

Status
Completed
 
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Investigative Site

Mitaka, Japan, 181-8611

Status
Completed
 
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Investigative Site

Itabashi-ku, Japan, 173-8606

Status
Completed
 
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Investigative Site

Chiba, Japan, 260-8677

Status
Completed
 
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Investigative Site

Matsumoto, Japan, 390-8621

Status
Completed
 
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Investigative Site

Nagoya, Japan, 467-8602

Status
Completed
 
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Investigative Site

Nagoya, Japan, 466-8560

Status
Completed
 
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Investigative Site

Osaka, Japan, 545-8586

Status
Completed
 
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Investigative Site

Hirakata, Japan, 573-1191

Status
Completed
 
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Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
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Investigative Site

Nagasaki, Japan, 852-8501

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1106

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1133

Status
Completed
 
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Investigative Site

Budapest, Hungary, 1083

Status
Completed
 
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Investigative Site

Debrecen, Hungary, 4032

Status
Completed
 
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Investigative Site

Zalaegerszeg, Hungary, H-8900

Status
Completed
 
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Investigative Site

Veszprem, Hungary, 8200

Status
Completed
 
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Investigative Site

Westmead, Australia, 2145

Status
Completed
 
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Investigative Site

Wroclaw, Poland, 50-556

Status
Completed
 
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Investigative Site

Praha 10, Czech Republic, 100 34

Status
Completed
 
Locations

Investigative Site

Berlin, Germany, 12203

Status
Completed
 
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Investigative Site

NANTES CEDEX, France, 44093

Status
Completed
 
Locations

Investigative Site

Kawasaki, Japan, 216-8511

Status
Completed
 
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Investigative Site

CRETEIL CEDEX, France, 94010

Status
Completed
 
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Investigative Site

Wakayama, Japan, 641-8510

Status
Completed
 
Locations

Investigative Site

Chiyoda-ku, Japan, 101-8309

Status
Completed
 

Trial Design