Trial Condition(s):

Macular Edema

Investigation of the change of vision-related quality of life in subjects treated with aflibercept according to EU label for DME. (AQUA)

Bayer Identifier:

17850

ClinicalTrials.gov Identifier:

NCT02581995

EudraCT Number:

2014-005119-17

Study Completed

Trial Purpose

To evaluate the change in quality of life (NEI VFQ 25) in subjects with DME during the first year of treatment with aflibercept according to the EU Label.

Inclusion Criteria
-  Type 1 or  2 diabetes mellitus
 -  Diagnosis of DME secondary to diabetes mellitus involving the center of the macula (defined as the area of the center subfield on OCT) in the study eye
 -  Decrease in vision determined to be primarily the result of DME in the study eye
 -  BCVA in the study eye of ETDRS letter score 73 to 24 (This corresponds to a Snellen equivalent of approximately 20/40 to 20/320.)
Exclusion Criteria
-  Pregnancy and lactation
 -  Mismatch with inclusion criteria

Trial Summary

Enrollment Goal
560
Trial Dates
black-arrow
Phase
4
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

Praha 10, Czech Republic, 100 34

Status
Completed
 
Locations

Investigative Site

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
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Investigative Site

Southampton, United Kingdom, SO16 6YD

Status
Completed
 
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Camberley, United Kingdom, GU16 7UJ

Status
Completed
 
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Budapest, Hungary, 1083

Status
Completed
 
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Budapest, Hungary, 1133

Status
Completed
 
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Debrecen, Hungary, 4032

Status
Completed
 
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Pecs, Hungary, 7621

Status
Completed
 
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Budapest, Hungary, 1106

Status
Completed
 
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Zvolen, Slovakia, 960 01

Status
Completed
 
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Bratislava, Slovakia, 85107

Status
Completed
 
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Guildford, United Kingdom, GU2 7XX

Status
Completed
 
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Sunderland, United Kingdom, SR2 9HP

Status
Completed
 
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Leeds, United Kingdom, LS9 7TF

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Completed
 
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London, United Kingdom, EC1V 2PD

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Completed
 
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Barcelona, Spain, 08036

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Completed
 
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L'Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
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Barcelona, Spain, 08035

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Completed
 
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Albacete, Spain, 02006

Status
Completed
 
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Valencia, Spain, 46014

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Completed
 
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San Cugat del Vallès, Spain, 08190

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Completed
 
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Nitra, Slovakia, 949 01

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Completed
 
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Bratislava, Slovakia, 826 06

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Completed
 
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Darmstadt, Germany, 64276

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Completed
 
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Köln, Germany, 50937

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Completed
 
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Göttingen, Germany, 37099

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Completed
 
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Frankfurt, Germany, 60596

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Completed
 
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Mainz, Germany, 55131

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Completed
 
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Dresden, Germany, 01067

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Completed
 
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Dresden, Germany, 01307

Status
Completed
 
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Leipzig, Germany, 04103

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Completed
 
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Bonn, Germany, 53105

Status
Completed
 
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CRETEIL CEDEX, France, 94010

Status
Completed
 
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Genova, Italy, 16132

Status
Completed
 
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Sassari, Italy, 07100

Status
Completed
 
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Torino, Italy, 10122

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Completed
 
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Roma, Italy, 00133

Status
Completed
 
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Milano, Italy, 20122

Status
Completed
 
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Firenze, Italy, 50134

Status
Completed
 
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Kaunas, Lithuania, LT-50009

Status
Completed
 
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Vilnius, Lithuania, LT-08661

Status
Completed
 
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Newcastle Upon Tyne, United Kingdom, NE1 4LP

Status
Completed
 
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Milano, Italy, 20132

Status
Completed
 
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Cagliari, Italy, 09124

Status
Completed
 
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Gdansk, Poland, 80-809

Status
Completed
 
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Lublin, Poland, 20-079

Status
Completed
 
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Padova, Italy, 35128

Status
Completed
 
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Sherbrooke, Canada, J1G 2V4

Status
Completed
 
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London, Canada, N6A 4V2

Status
Completed
 
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Montreal, Canada, H4P 2S4

Status
Completed
 
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Halifax, Canada, B3H 2Y9

Status
Completed
 
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Usti nad Labem, Czech Republic, 401 13

Status
Completed
 
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Porto, Portugal, 4200-319

Status
Completed
 
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Wien, Austria, 1140

Status
Completed
 
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Wien, Austria, 1090

Status
Completed
 
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Graz, Austria, 8036

Status
Completed
 
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Marburg, Germany, 35043

Status
Completed
 
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Ludwigshafen, Germany, 67063

Status
Completed
 
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Toronto, Canada, M3C 0G9

Status
Completed
 
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Ottawa, Canada, K1H 8L6

Status
Completed
 
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Mississauga, Canada, L4W 1W9

Status
Completed
 
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Investigative Site

Krakow, Poland, 31-501

Status
Completed
 
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Bydgoszcz, Poland, 85-631

Status
Completed
 
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Leiria, Portugal, 2410-197

Status
Completed
 
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Lisboa, Portugal, 1649-035

Status
Completed
 
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Vila Franca de Xira, Portugal, 2600-178

Status
Completed
 
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Coimbra, Portugal, 3000-548

Status
Completed
 
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Bern, Switzerland

Status
Completed
 
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Warszawa, Poland, 01-013

Status
Completed
 
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Poznan, Poland, 61-285

Status
Completed
 
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Warszawa, Poland, 04-141

Status
Completed
 
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Lodz, Poland, 91-134

Status
Completed
 
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Katowice, Poland, 40-594

Status
Completed
 
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Genève, Switzerland, 1204

Status
Completed
 
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MARSEILLE, France, 13285

Status
Completed
 
Locations

Investigative Site

Zilina, Slovakia, 01207

Status
Completed
 

Trial Design