Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

NCT ID: NCT01318941

Last Updated: 2016-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30490 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2016-04-30

Brief Summary

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This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.

Detailed Description

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Conditions

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Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion Wet Age Related Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ranibizumab

Ranibizumab

Intervention Type DRUG

Ranibizumab

Intervention Type OTHER

Interventions

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Ranibizumab

Intervention Type DRUG

Ranibizumab

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult patients, within age limits as defined by local regulations and local product label, who have previously been treated with, who are currently being treated with or initiating treatment with ranibizumab for any approved indication included in the local product label
* Willing and able to provide informed written consent personally or by legal proxy

Exclusion Criteria

* Simultaneous participation in a study that includes administration of any investigational drug or procedure
* Systemic or ocular treatment with any VEGF inhibitor other than ranibizumab in the 90 days prior to enrollment
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Porlamar Local 02, Isla Margarita, Venezuela

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Caracas, , Venezuela

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Torre Venezuela, Piso 1, , Venezuela

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Caracas, Piso 6, Ofic. 607, , Venezuela

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Santa Paula, , Venezuela

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Buenos Aires, Argentina, Argentina

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Concepción del Uruguay, Argentina, Argentina

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Córdoba, Argentina, Argentina

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Guaymallén, Mendoza, Argentina, Argentina

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Rosario, Argentina, Argentina

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San Martin, Buenos Aires, Argentina, Argentina

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Santa Fe, Argentina, Argentina

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Lanús, Buenos Aires, Argentina

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Mar del Plata, Buenos Aires, Argentina

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Rosario, Santa Fe Province, Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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Caballito, , Argentina

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Ciudad de Buenos Aires,, , Argentina

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La Plata, , Argentina

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Santa Fe, , Argentina

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Chatswood, New South Wales, Australia

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Forster, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Liverpool, New South Wales, Australia

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North Ryde, New South Wales, Australia

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Parramatta, New South Wales, Australia

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Strathfield, New South Wales, Australia

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Sydney, New South Wales, Australia

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Sydney, New South Wales, Australia

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Westmead, New South Wales, Australia

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Brisbane, Queensland, Australia

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South Brisbane, Queensland, Australia

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Southport, Queensland, Australia

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Adelaide, South Australia, Australia

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North Adelaide, South Australia, Australia

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Hobart, Tasmania, Australia

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South Launceston, Tasmania, Australia

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East Melbourne, Victoria, Australia

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Geelong, Victoria, Australia

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Glen Waverley, Victoria, Australia

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Oakleigh, Victoria, Australia

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Linz, , Austria

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Vienna, , Austria

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Aalst, Belgium, Belgium

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Aarschot, Belgium, Belgium

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Bonheiden, , Belgium

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Brussels, , Belgium

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Dinant, , Belgium

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Edegem, , Belgium

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Ghent, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Mouscron, , Belgium

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Namur, , Belgium

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Nivelles, , Belgium

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Reet, , Belgium

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Yvoir, , Belgium

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Zottegem, , Belgium

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Goiânia, Goiás, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Campinas, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Calgary, Alberta, Canada

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Victoria, British Columbia, Canada

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Miramichi, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Downsview, Ontario, Canada

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East Brockville, Ontario, Canada

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London, Ontario, Canada

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Ottawa, Ontario, Canada

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Ottawa, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Toronto, Ontario, Canada

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Vaughan, Ontario, Canada

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Boisbriand, Quebec, Canada

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Barrie, , Canada

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Drummondville, , Canada

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Hamilton, , Canada

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Ontario, , Canada

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Calama, , Chile

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Beijing, Beijing Municipality, China

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Beijing, Beijing Municipality, China

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Beijing, Beijing Municipality, China

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Guangzhou, Guangdong, China

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Guiyang, Guizhou, China

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Wuhan, Hubei, China

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Jinan, Shandong, China

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Tianjin, Tianjin Municipality, China

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Kunming, Yunnan, China

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Beijing, , China

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Beijing, , China

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Beijing, , China

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Changchun, , China

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Chongqing, , China

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Fujian, , China

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Shanghai, , China

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Shanghai, , China

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Shanghai, , China

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Ürümqi, , China

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Barranquilla, Atlántico, Colombia

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Armenia, Quindío Department, Colombia

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Bogotá, , Colombia

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Cali, , Colombia

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Yopal, , Colombia

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San José, Costa Rica, Costa Rica

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Brno - Bohunice, Czech Republic, Czechia

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Hradec Králové, , Czechia

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Olomouc, , Czechia

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Ostrava-Poruba, , Czechia

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Pilsen, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Ustri Nad Labem, , Czechia

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Santo Domingo, Republica Dominicana, Dominican Republic

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Ciudadela Kennedy, Guayaquil, Ecuador

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Cairo, Cairo Governorate, Egypt

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Giza, , Egypt

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Poitiers, France, France

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Bordeaux, , France

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Créteil, , France

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Dijon, , France

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Lyon, , France

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Montauban, , France

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Nice, , France

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Paris, , France

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Reims, , France

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Toulouse, , France

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Vannes, , France

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Augsburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Cologne, , Germany

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Dannenberg, , Germany

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Hamburg, , Germany

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Ingolstadt, , Germany

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Lüdenscheid, , Germany

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Münster, , Germany

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Münster, , Germany

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Neu-Ulm, , Germany

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Osnabrück, , Germany

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Regensburg, , Germany

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Rothenburg, , Germany

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Schriesheim, , Germany

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Tönisvorst, , Germany

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Tübingen, , Germany

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Alexandroupoli, Greece, Greece

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Athens, Greece, Greece

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Athens, Greece, Greece

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Athens, GR, Greece

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Heraklion - Crete, GR, Greece

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Larissa, GR, Greece

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Patra - RIO, GR, Greece

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Rethymno, GR, Greece

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Thessaloniki, GR, Greece

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Athens, , Greece

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Lamia, Phthiotis, , Greece

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Guatemala City, Departamento de Guatemala, Guatemala

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Kowloon, Hong Kong, Hong Kong

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Patia, Bhudaneswar, India

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Chennai, Tamil Nadu, India

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Coimbatore, Tamil Nadu, India

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Hyderabad, Telangana, India

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Ahmedabad, , India

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New Delhi, , India

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Dublin, , Ireland

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Dublin, , Ireland

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Waterford, , Ireland

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Haifa, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Acquaviva delle Fonti, BA, Italy

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Cagliari, CA, Italy

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Genova, GE, Italy

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Alessandria, , Italy

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Belluno, , Italy

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Brescia, , Italy

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Pisa, , Italy

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Reggio Calabria, , Italy

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Roma, , Italy

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Roma, , Italy

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Nagakute, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Toyoake, Aichi-ken, Japan

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Aomori, Aomori, Japan

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Sakura, Chiba, Japan

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Matsuyama, Ehime, Japan

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Yoshida-gun, Fukui, Japan

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Fukuoka, Fukuoka, Japan

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Fukuoka, Fukuoka, Japan

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Kitakyushu, Fukuoka, Japan

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Fukushima, Fukushima, Japan

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Maebashi, Gunma, Japan

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Hiroshima, Hiroshima, Japan

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Sapporo, Hokkaido, Japan

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Sapporo, Hokkido, Japan

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Amagasaki, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Inashiki-gun, Ibaraki, Japan

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Tsukuba, Ibaraki, Japan

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Kanazawa, Ishikawa-ken, Japan

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Kita-gun, Kagawa-ken, Japan

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Ashigarakami-gun, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Yokosuka, Kanagawa, Japan

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Yokohama, Kangawa, Japan

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Kyoto, Kyoto, Japan

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Tsu, Mie-ken, Japan

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Sendai, Miyagi, Japan

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Miyakonojō, Miyazaki, Japan

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Miyazaki, Miyazaki, Japan

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Suwa, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Kashihara, Nara, Japan

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Hirakata, Osaka, Japan

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Osaka, Osaka, Japan

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Sayama, Osaka, Japan

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Saitama, Saitama, Japan

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Saitama, Saitama, Japan

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Hamamatsu, Shizuoka, Japan

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Izunokuni, Shizuoka, Japan

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Shizuoka, Shizuoka, Japan

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Shimotsuka-gun, Tochigi, Japan

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Tokushima, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Mitaka, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Shinjuku-ku, Tokyo, Japan

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Urayasu, Tokyo, Japan

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Imizu-shi, Toyama, Japan

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Toyama, Toyama, Japan

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Yamagata, Yamagata, Japan

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Chūō, Yamanashi, Japan

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Akita, , Japan

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Chiyoda-ku, , Japan

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Ehime, , Japan

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Gifu, , Japan

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Hamamatsu, , Japan

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Hokkaido, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ishikawa, , Japan

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Kagoshima, , Japan

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Kagoshima, , Japan

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Kakogawa-shi, , Japan

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Kanagawa, , Japan

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Kawasaki-shi, , Japan

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Kitami-shi, , Japan

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Koriyama-shi, , Japan

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Kouchi, , Japan

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Kyoto, , Japan

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Miyagi, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

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Nantan-shi, , Japan

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Osaka, , Japan

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Ōtsu, , Japan

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Saitama-ken, , Japan

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Sanjo-shi, , Japan

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Shizuoka, , Japan

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Shunan-shi, , Japan

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Tochigi, , Japan

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Tokyo, , Japan

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Tokyo, , Japan

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Toyohashi, , Japan

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Wakayama, , Japan

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Yamagata, , Japan

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Batu Caves, Selangor, Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Kuala Lumpur, , Malaysia

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Col. Lomas de Chapultepec, CP, Mexico

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Mexico City, Mexico City, Mexico

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Mexico City, Mexico City, Mexico

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Monterray, Nuevo León, Mexico

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Monterrey, Nuevo León, Mexico

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Mérida, Yucatán, Mexico

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Almere Stad, , Netherlands

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Amsterdam, , Netherlands

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Tilburg, , Netherlands

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Panama City, Provincia de Panamá, Panama

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Panama City, Provincia de Panamá, Panama

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Lima, Lima Province, Peru

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San Borja, Lima region, Peru

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San Isidro, Lima region, Peru

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Bydgoszcz, , Poland

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Chojnice, , Poland

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Chorzów, , Poland

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Gdansk, , Poland

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Gda¿sk, , Poland

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Kalisz, , Poland

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Kielce, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Olsztyn, , Poland

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Poznan, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wałbrzych, , Poland

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Wołomin, , Poland

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Coimbra, Portugal, Portugal

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Coimbra, Portugal, Portugal

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Aveiro, , Portugal

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Leiria, , Portugal

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Lisbon, , Portugal

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Matosinhos Municipality, , Portugal

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Santa Maria da Feira, , Portugal

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Cheboksary, , Russia

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Chelyabinsk, , Russia

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Chita, , Russia

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Irkutsk, , Russia

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Kazan', , Russia

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Khabarovsk, , Russia

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Krasnodar, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Penza, , Russia

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Saint Petersburg, , Russia

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Samara, , Russia

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Saratov, , Russia

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Surgut, , Russia

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Tambov, , Russia

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Tyumen, , Russia

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Ufa, , Russia

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Yakutsk, , Russia

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Riyadh, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Riyadh, , Saudi Arabia

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Singapore, Singapore, Singapore

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Singapore, , Singapore

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Singapore, , Singapore

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Banksa Bystrica, Slovak Republic, Slovakia

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Trebišov, Slovak Republic, Slovakia

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Bratislava, Slovakia, Slovakia

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Nové Zámky, Slovakia, Slovakia

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Zvolen, Slovakia, Slovakia

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Žilina, Slovakia, Slovakia

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Bratislava, , Slovakia

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Bratislava, , Slovakia

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Ljubljana, , Slovakia

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Poprad, , Slovakia

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Ružomberok, , Slovakia

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Trenčín, , Slovakia

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Novo Mesto, Slovenia, Slovenia

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Celje, , Slovenia

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Ljubljana, , Slovenia

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Maribor, , Slovenia

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Seongnam-si, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Pusan, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Taegu, , South Korea

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Málaga, Andalusia, Spain

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León, Castille and León, Spain

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Salamanca, Castille and León, Spain

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Valladolid, Castille and León, Spain

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Barcelona, Catalonia, Spain

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Sant Cugat del Vallès, Catalonia, Spain

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Tarragona, Catalonia, Spain

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Lugo, Galicia, Spain

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Logroño, Hospital La Rioja Provincia, Spain

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Murcia, Murcia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Zaragoza, Zaragoza, Spain

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Barcelona, , Spain

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Burgos, , Spain

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Granollers, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Zaragoza, , Spain

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Ankara, Turkey, Turkey (Türkiye)

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Altindag / Ankara, , Turkey (Türkiye)

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Ankara, , Turkey (Türkiye)

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Mecidiyekoy/Istanbul, , Turkey (Türkiye)

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Dnipropetrovsk, , Ukraine

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Kyiv, , Ukraine

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Luhansk, , Ukraine

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Odesa, , Ukraine

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Truro, Cornwall, United Kingdom

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Durham, County Durham, United Kingdom

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Torquay, Devon,, United Kingdom

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Bolton, England, United Kingdom

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Solihull, England, United Kingdom

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Southampton, England, United Kingdom

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Wakefield, England, United Kingdom

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Belfast, Essex, United Kingdom

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Romford, Essex, United Kingdom

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Cheltenham, Gloucestershire, United Kingdom

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Blackburn, Lancashire, United Kingdom

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Hull, Lancashire, United Kingdom

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Leicester, Lancashire, United Kingdom

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Coventry, London, United Kingdom

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Derby, London, United Kingdom

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Leytonstone, London, United Kingdom

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Oxford, Oxfordshire, United Kingdom

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Sheffield, South Yorkshire, United Kingdom

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Stoke-on-Trent, Staffordshire, United Kingdom

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Frimley, Surrey, United Kingdom

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Guildford, Surrey, United Kingdom

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Worcester, UK, United Kingdom

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London, United Kingdom, United Kingdom

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Bradford, West Yorkshire, United Kingdom

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Bedford, , United Kingdom

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Birmingham, , United Kingdom

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Bristol, , United Kingdom

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Cardiff, , United Kingdom

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Cheshire, , United Kingdom

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Colchester, , United Kingdom

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Inverness, , United Kingdom

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Kent, , United Kingdom

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Maidstone, , United Kingdom

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Manchester, , United Kingdom

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Merseyside, , United Kingdom

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Merseyside, , United Kingdom

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Middlesbrough, , United Kingdom

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Newport, , United Kingdom

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Portsmouth, , United Kingdom

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Southend, , United Kingdom

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Sunderland, , United Kingdom

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Uxbridge, , United Kingdom

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Wolverhampton, , United Kingdom

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York, , United Kingdom

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Countries

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Argentina Australia Austria Belgium Brazil Canada Chile China Colombia Costa Rica Czechia Dominican Republic Ecuador Egypt France Germany Greece Guatemala Hong Kong Hungary India Ireland Israel Italy Japan Malaysia Mexico Netherlands Panama Peru Poland Portugal Russia Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Turkey (Türkiye) Ukraine United Kingdom Venezuela

References

Explore related publications, articles, or registry entries linked to this study.

Holz FG, Minnella AM, Tuli R, Yoganathan P, Parikh S, Hamilton R; LUMINOUS study group. Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PLoS One. 2020 Dec 30;15(12):e0244183. doi: 10.1371/journal.pone.0244183. eCollection 2020.

Reference Type DERIVED
PMID: 33378369 (View on PubMed)

Leys AM, Ramboer E, Favreau M, Denhaerynck K, MacDonald K, Abraham I, Brie H. Long-Term Ranibizumab Treatment in Neovascular Age-Related Macular Degeneration: A Belgian Subanalysis from the Global Real-World LUMINOUSTM Study. Clin Ophthalmol. 2020 Jun 2;14:1473-1481. doi: 10.2147/OPTH.S242547. eCollection 2020.

Reference Type DERIVED
PMID: 32581505 (View on PubMed)

Pearce I, Clemens A, Brent MH, Lu L, Gallego-Pinazo R, Minnella AM, Creuzot-Garcher C, Spital G, Sakamoto T, Dunger-Baldauf C, McAllister IL; all the LUMINOUS study investigators. Real-world outcomes with ranibizumab in branch retinal vein occlusion: The prospective, global, LUMINOUS study. PLoS One. 2020 Jun 18;15(6):e0234739. doi: 10.1371/journal.pone.0234739. eCollection 2020.

Reference Type DERIVED
PMID: 32555630 (View on PubMed)

Mitchell P, Sheidow TG, Farah ME, Mahmood S, Minnella AM, Eter N, Eldem B, Al-Dhibi H, Macfadden W, Parikh S, Dunger-Baldauf C, Mahgoub MM, Schmidt-Erfurth U; LUMINOUS study investigators. Effectiveness and safety of ranibizumab 0.5 mg in treatment-naive patients with diabetic macular edema: Results from the real-world global LUMINOUS study. PLoS One. 2020 Jun 3;15(6):e0233595. doi: 10.1371/journal.pone.0233595. eCollection 2020.

Reference Type DERIVED
PMID: 32492069 (View on PubMed)

Schmidt-Erfurth U, Chong V, Loewenstein A, Larsen M, Souied E, Schlingemann R, Eldem B, Mones J, Richard G, Bandello F; European Society of Retina Specialists. Guidelines for the management of neovascular age-related macular degeneration by the European Society of Retina Specialists (EURETINA). Br J Ophthalmol. 2014 Sep;98(9):1144-67. doi: 10.1136/bjophthalmol-2014-305702.

Reference Type DERIVED
PMID: 25136079 (View on PubMed)

Other Identifiers

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CRFB002A2406

Identifier Type: -

Identifier Source: org_study_id

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