Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

Diabetic Macular Edema Clinical Trial

— LUMINOUS  

Official title:

LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318941
• Other study ID #: CRFB002A2406
• Status: Completed
• Phase: N/A
• First received: March 17, 2011
• Last updated: May 20, 2016
• Start date: March 2011
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaSingapore: HASAustria: AGESGermany: BfArmPoland: UPRLSlovakia: SUKLSingapore: Health Sciences AuthorityCosta Rica: Ethics CommitteeDominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS)Guatemala: Ministry of Public Health and Social AssistancePanama: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30490
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

• Other protocol-defined inclusion/exclusion criteria may apply

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Drug:
• Ranibizumab

Other:
• Ranibizumab

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Caballito
Argentina	Novartis Investigative Site	Ciudad de Buenos Aires,
Argentina	Novartis Investigative Site	Concepción del Uruguay
Argentina	Novartis Investigative Site	Córdoba
Argentina	Novartis Investigative Site	Guaymallén, Mendoza
Argentina	Novartis Investigative Site	La Plata
Argentina	Novartis Investigative Site	Lanus	Buenos Aires
Argentina	Novartis Investigative Site	Mar del Plata	Buenos Aires
Argentina	Novartis Investigative Site	Rosario	Santa Fe
Argentina	Novartis Investigative Site	Rosario
Argentina	Novartis Investigative Site	San Martin, Buenos Aires
Argentina	Novartis Investigative Site	Santa Fe
Argentina	Novartis Investigative Site	Santa Fe
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Brisbane	Queensland
Australia	Novartis Investigative Site	Chatswood	New South Wales
Australia	Novartis Investigative Site	East Melbourne	Victoria
Australia	Novartis Investigative Site	Forster	New South Wales
Australia	Novartis Investigative Site	Geelong	Victoria
Australia	Novartis Investigative Site	Glen Waverley	Victoria
Australia	Novartis Investigative Site	Hobart	Tasmania
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Liverpool	New South Wales
Australia	Novartis Investigative Site	North Adelaide	South Australia
Australia	Novartis Investigative Site	North Ryde	New South Wales
Australia	Novartis Investigative Site	Oakleigh	Victoria
Australia	Novartis Investigative Site	Parramatta	New South Wales
Australia	Novartis Investigative Site	South Brisbane	Queensland
Australia	Novartis Investigative Site	South Launceston	Tasmania
Australia	Novartis Investigative Site	Southport	Queensland
Australia	Novartis Investigative Site	Strathfield	New South Wales
Australia	Novartis Investigative Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Sydney	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Austria	Novartis Investigative Site	Linz
Austria	Novartis Investigative Site	Vienna
Belgium	Novartis Investigative Site	Aalst
Belgium	Novartis Investigative Site	Aarschot
Belgium	Novartis Investigative Site	Bonheiden
Belgium	Novartis Investigative Site	Bruxelles
Belgium	Novartis Investigative Site	Dinant
Belgium	Novartis Investigative Site	Edegem
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Hasselt
Belgium	Novartis Investigative Site	Leuven
Belgium	Novartis Investigative Site	Mouscron
Belgium	Novartis Investigative Site	Namur
Belgium	Novartis Investigative Site	Nivelles
Belgium	Novartis Investigative Site	Reet
Belgium	Novartis Investigative Site	Yvoir
Belgium	Novartis Investigative Site	Zottegem
Brazil	Novartis Investigative Site	Belo Horizonte	MG
Brazil	Novartis Investigative Site	Campinas	SP
Brazil	Novartis Investigative Site	Goiania	GO
Brazil	Novartis Investigative Site	Porto Alegre	RS
Brazil	Novartis Investigative Site	Rio de Janeiro	RJ
Brazil	Novartis Investigative Site	São Paulo	SP
Canada	Novartis Investigative Site	Barrie
Canada	Novartis Investigative Site	Boisbriand	Quebec
Canada	Novartis Investigative Site	Brampton	Ontario
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Downsview	Ontario
Canada	Novartis Investigative Site	Drummondville
Canada	Novartis Investigative Site	East Brockville	Ontario
Canada	Novartis Investigative Site	Halifax	Nova Scotia
Canada	Novartis Investigative Site	Hamilton
Canada	Novartis Investigative Site	London	Ontario
Canada	Novartis Investigative Site	Miramichi	New Brunswick
Canada	Novartis Investigative Site	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Ottawa	Ontario
Canada	Novartis Investigative Site	Scarborough	Ontario
Canada	Novartis Investigative Site	Toronto	Ontario
Canada	Novartis Investigative Site	Vaughan	Ontario
Canada	Novartis Investigative Site	Victoria	British Columbia
Chile	Novartis Investigative Site	Calama
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Beijing
China	Novartis Investigative Site	Changchun City
China	Novartis Investigative Site	Chongqing
China	Novartis Investigative Site	Fujian
China	Novartis Investigative Site	Guangzhou	Guangdong
China	Novartis Investigative Site	Guiyang	Guizhou
China	Novartis Investigative Site	Jinan	Shandong
China	Novartis Investigative Site	Kunming City	Yunnan
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Shanghai
China	Novartis Investigative Site	Tianjin	Tianjin
China	Novartis Investigative Site	Wuhan	Hubei
China	Novartis Investigative Site	Wulumuqi City
Colombia	Novartis Investigative Site	Armenia	Quindío
Colombia	Novartis Investigative Site	Barranquilla	Atlantico
Colombia	Novartis Investigative Site	Bogota
Colombia	Novartis Investigative Site	Bogotá
Colombia	Novartis Investigative Site	Cali
Colombia	Novartis Investigative Site	Yopal
Costa Rica	Novartis Investigative Site	San Jose
Czech Republic	Novartis Investigative Site	Brno - Bohunice
Czech Republic	Novartis Investigative Site	Hradec Kralove
Czech Republic	Novartis Investigative Site	Olomouc
Czech Republic	Novartis Investigative Site	Ostrava-Poruba
Czech Republic	Novartis Investigative Site	Plzen
Czech Republic	Novartis Investigative Site	Praha
Czech Republic	Novartis Investigative Site	Praha
Czech Republic	Novartis Investigative Site	Praha 10
Czech Republic	Novartis Investigative Site	Ustri nad Labem
Dominican Republic	Novartis Investigative Site	Santo Domingo	Republica Dominicana
Ecuador	Novartis Investigative Site	Ciudadela Kennedy	Guayaquil
Egypt	Novartis Investigative Site	Cairo
Egypt	Novartis Investigative Site	Giza
France	Novartis Investigative Site	Bordeaux
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Dijon
France	Novartis Investigative Site	Lyon CEDEX 04
France	Novartis Investigative Site	Melun
France	Novartis Investigative Site	Montargis
France	Novartis Investigative Site	Montauban
France	Novartis Investigative Site	Nantes Cedex 1
France	Novartis Investigative Site	Nice
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris
France	Novartis Investigative Site	Paris cedex 10
France	Novartis Investigative Site	Paris Cedex 19
France	Novartis Investigative Site	Poitiers
France	Novartis Investigative Site	Reims
France	Novartis Investigative Site	Toulouse Cedex 9
France	Novartis Investigative Site	Vannes
Germany	Novartis Investigative Site	Augsburg
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Bonn
Germany	Novartis Investigative Site	Dannenberg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Ingolstadt
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Luedenscheid
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Muenster
Germany	Novartis Investigative Site	Neu-Ulm
Germany	Novartis Investigative Site	Osnabrück
Germany	Novartis Investigative Site	Regensburg
Germany	Novartis Investigative Site	Rothenburg
Germany	Novartis Investigative Site	Schriesheim
Germany	Novartis Investigative Site	Tönisvorst
Germany	Novartis Investigative Site	Tuebingen
Greece	Novartis Investigative Site	Alexandroupolis
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens
Greece	Novartis Investigative Site	Athens	GR
Greece	Novartis Investigative Site	Heraklion - Crete	GR
Greece	Novartis Investigative Site	Lamia, Phthiotis
Greece	Novartis Investigative Site	Larissa	GR
Greece	Novartis Investigative Site	Patra - RIO	GR
Greece	Novartis Investigative Site	Rethymno	GR
Greece	Novartis Investigative Site	Thessaloniki	GR
Guatemala	Novartis Investigative Site	Guatemala City
Hong Kong	Novartis Investigative Site	Kowloon
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szeged
India	Novartis Investigative Site	Ahmedabad
India	Novartis Investigative Site	Chennai	Tamil Nadu
India	Novartis Investigative Site	Coimbatore	Tamil Nadu
India	Novartis Investigative Site	Hyderabad	Telangana
India	Novartis Investigative Site	New Delhi
India	Novartis Investigative Site	Patia	Bhudaneswar
Ireland	Novartis Investigative Site	Dublin
Ireland	Novartis Investigative Site	Dublin 7
Ireland	Novartis Investigative Site	Waterford
Israel	Novartis Investigative Site	Haifa
Israel	Novartis Investigative Site	Petach Tikva
Israel	Novartis Investigative Site	Tel Aviv
Italy	Novartis Investigative Site	Acquaviva delle Fonti	BA
Italy	Novartis Investigative Site	Alessandria
Italy	Novartis Investigative Site	Belluno
Italy	Novartis Investigative Site	Brescia
Italy	Novartis Investigative Site	Cagliari	CA
Italy	Novartis Investigative Site	Genova	GE
Italy	Novartis Investigative Site	Pisa
Italy	Novartis Investigative Site	Reggio Calabria
Italy	Novartis Investigative Site	Roma
Italy	Novartis Investigative Site	Roma
Japan	Novartis Investigative Site	Akita
Japan	Novartis Investigative Site	Amagasaki-city	Hyogo
Japan	Novartis Investigative Site	Aomori
Japan	Novartis Investigative Site	Ashigarakami-gun	Kanagawa
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Chiyoda-ku
Japan	Novartis Investigative Site	Chuo-city	Yamanashi
Japan	Novartis Investigative Site	Ehime
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukushima-city	Fukushima
Japan	Novartis Investigative Site	Gifu
Japan	Novartis Investigative Site	Hamamatsu-city	Shizuoka
Japan	Novartis Investigative Site	Hamamatsu-shi
Japan	Novartis Investigative Site	Hirakata-city	Osaka
Japan	Novartis Investigative Site	Hiroshima-city	Hiroshima
Japan	Novartis Investigative Site	Hokkaido
Japan	Novartis Investigative Site	Hokkaido
Japan	Novartis Investigative Site	Hyogo
Japan	Novartis Investigative Site	Imizu-shi	Toyama
Japan	Novartis Investigative Site	Inashiki-gun	Ibaraki
Japan	Novartis Investigative Site	Ishikawa
Japan	Novartis Investigative Site	Izunokuni	Shizuoka
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Kagoshima
Japan	Novartis Investigative Site	Kakogawa-shi
Japan	Novartis Investigative Site	Kanagawa
Japan	Novartis Investigative Site	Kanazawa-city	Ishikawa
Japan	Novartis Investigative Site	Kashihara-city	Nara
Japan	Novartis Investigative Site	Kawasaki-shi
Japan	Novartis Investigative Site	Kita-gun	Kagawa
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitami-shi
Japan	Novartis Investigative Site	Kobe	Hyogo
Japan	Novartis Investigative Site	Koriyama-shi
Japan	Novartis Investigative Site	Kouchi
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-shi
Japan	Novartis Investigative Site	Maebashi-city	Gunma
Japan	Novartis Investigative Site	Matsuyama	Ehime
Japan	Novartis Investigative Site	Mitaka-city	Tokyo
Japan	Novartis Investigative Site	Miyagi
Japan	Novartis Investigative Site	Miyakonojo-City	Miyazakiken
Japan	Novartis Investigative Site	Miyazaki-city	Miyazaki
Japan	Novartis Investigative Site	Nagakute-city	Aichi
Japan	Novartis Investigative Site	Nagano
Japan	Novartis Investigative Site	Nagasaki-city	Nagasaki
Japan	Novartis Investigative Site	Nagasaki-shi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nagoya-city	Aichi
Japan	Novartis Investigative Site	Nagoya-City	Aichi
Japan	Novartis Investigative Site	Nantan-shi
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Nishinomiya	Hyogo
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	OsakaSayama	Osaka
Japan	Novartis Investigative Site	Otsu-shi
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Saitama-city	Saitama
Japan	Novartis Investigative Site	Saitama-ken
Japan	Novartis Investigative Site	Sakura	Chiba
Japan	Novartis Investigative Site	Sanjo-shi
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkido
Japan	Novartis Investigative Site	Sendai	Miyagi
Japan	Novartis Investigative Site	Shimotsuka-gun	Tochigi
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Shizuoka
Japan	Novartis Investigative Site	Shizuoka-shi
Japan	Novartis Investigative Site	Shunan-shi
Japan	Novartis Investigative Site	Suwa	Nagano
Japan	Novartis Investigative Site	Tochigi
Japan	Novartis Investigative Site	Tokushima-city	Tokushima
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Tokyo
Japan	Novartis Investigative Site	Toyama
Japan	Novartis Investigative Site	Toyoake-city	Aichi
Japan	Novartis Investigative Site	Toyohashi-shi
Japan	Novartis Investigative Site	Tsu-city	Mie
Japan	Novartis Investigative Site	Tsukuba-city	Ibaraki
Japan	Novartis Investigative Site	Urayasu	Tokyo
Japan	Novartis Investigative Site	Wakayama
Japan	Novartis Investigative Site	Yamagata
Japan	Novartis Investigative Site	Yamagata
Japan	Novartis Investigative Site	Yokohama	Kangawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokosuka-city	Kanagawa
Japan	Novartis Investigative Site	Yoshida-gun	Fukui
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Daegu
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seongnam	Gyeonggi
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Seoul
Korea, Republic of	Novartis Investigative Site	Suwon	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Taegu
Malaysia	Novartis Investigative Site	Batu Caves	Selangor
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Lumpur
Malaysia	Novartis Investigative Site	Kuala Lumpur
Mexico	Novartis Investigative Site	Ciudad De Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Ciudad De Mexico	Distrito Federal
Mexico	Novartis Investigative Site	Col. Lomas de Chapultepec	CP
Mexico	Novartis Investigative Site	Mérida	Yucatán
Mexico	Novartis Investigative Site	Monterray	Nuevo León
Mexico	Novartis Investigative Site	Monterrey	Nuevo León
Netherlands	Novartis Investigative Site	Almere
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Tilburg
Panama	Novartis Investigative Site	Panama	Panamá
Panama	Novartis Investigative Site	Panama City	Panamá
Peru	Novartis Investigative Site	Lima
Peru	Novartis Investigative Site	San Borja	Lima
Peru	Novartis Investigative Site	San Isidro	Lima
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Chojnice
Poland	Novartis Investigative Site	Chorzow
Poland	Novartis Investigative Site	Gda¿sk
Poland	Novartis Investigative Site	Gdansk
Poland	Novartis Investigative Site	Kalisz
Poland	Novartis Investigative Site	Kielce
Poland	Novartis Investigative Site	Krakow
Poland	Novartis Investigative Site	Lodz
Poland	Novartis Investigative Site	Olsztyn
Poland	Novartis Investigative Site	Poznan
Poland	Novartis Investigative Site	Walbrzych
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Wolomin
Portugal	Novartis Investigative Site	Aveiro
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Coimbra
Portugal	Novartis Investigative Site	Leiria
Portugal	Novartis Investigative Site	Lisboa
Portugal	Novartis Investigative Site	Matosinhos
Portugal	Novartis Investigative Site	Santa Maria Da Feira
Russian Federation	Novartis Investigative Site	Cheboksary
Russian Federation	Novartis Investigative Site	Chelyabinsk
Russian Federation	Novartis Investigative Site	Chita
Russian Federation	Novartis Investigative Site	Irkutsk
Russian Federation	Novartis Investigative Site	Kazan
Russian Federation	Novartis Investigative Site	Khabarovsk
Russian Federation	Novartis Investigative Site	Krasnodar
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	Novosibirsk
Russian Federation	Novartis Investigative Site	Penza
Russian Federation	Novartis Investigative Site	Saint Petersburg
Russian Federation	Novartis Investigative Site	Samara
Russian Federation	Novartis Investigative Site	Saratov
Russian Federation	Novartis Investigative Site	Surgut
Russian Federation	Novartis Investigative Site	Tambov
Russian Federation	Novartis Investigative Site	Tyumen
Russian Federation	Novartis Investigative Site	Ufa
Russian Federation	Novartis Investigative Site	Yakutsk
Saudi Arabia	Novartis Investigative Site	Riyadh
Saudi Arabia	Novartis Investigative Site	Riyadh
Saudi Arabia	Novartis Investigative Site	Riyadh
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Singapore	Novartis Investigative Site	Singapore
Slovakia	Novartis Investigative Site	Banksa Bystrica	Slovak Republic
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Bratislava
Slovakia	Novartis Investigative Site	Ljubljana
Slovakia	Novartis Investigative Site	Nove Zamky
Slovakia	Novartis Investigative Site	Poprad
Slovakia	Novartis Investigative Site	Ruzomberok
Slovakia	Novartis Investigative Site	Trebisov	Slovak Republic
Slovakia	Novartis Investigative Site	Trencin
Slovakia	Novartis Investigative Site	Zilina
Slovakia	Novartis Investigative Site	Zvolen
Slovenia	Novartis Investigative Site	Celje
Slovenia	Novartis Investigative Site	Ljubljana
Slovenia	Novartis Investigative Site	Maribor
Slovenia	Novartis Investigative Site	Novo Mesto
Spain	Novartis Investigative Site	Barcelona
Spain	Novartis Investigative Site	Barcelona	Cataluña
Spain	Novartis Investigative Site	Burgos
Spain	Novartis Investigative Site	Granollers
Spain	Novartis Investigative Site	Leon	Castilla y Leon
Spain	Novartis Investigative Site	Logroño	Hospital La Rioja provincia
Spain	Novartis Investigative Site	Lugo	Galicia
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Madrid
Spain	Novartis Investigative Site	Malaga	Andalucia
Spain	Novartis Investigative Site	Murcia
Spain	Novartis Investigative Site	Salamanca	Castilla y Leon
Spain	Novartis Investigative Site	Sant Cugat	Catalunya
Spain	Novartis Investigative Site	Tarragona	Catalunya
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Spain	Novartis Investigative Site	Valladolid	Castilla y Leon
Spain	Novartis Investigative Site	Zaragoza
Turkey	Novartis Investigative Site	Altindag / Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Mecidiyekoy/Istanbul
Ukraine	Novartis Investigative Site	Dnipropetrovsk
Ukraine	Novartis Investigative Site	Kyev
Ukraine	Novartis Investigative Site	Lugansk
Ukraine	Novartis Investigative Site	Odesa
United Kingdom	Novartis Investigative Site	Bedford
United Kingdom	Novartis Investigative Site	Belfast	Essex
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Blackburn	Lancashire
United Kingdom	Novartis Investigative Site	Bolton	England
United Kingdom	Novartis Investigative Site	Bradford	West Yorkshire
United Kingdom	Novartis Investigative Site	Bristol
United Kingdom	Novartis Investigative Site	Cardiff
United Kingdom	Novartis Investigative Site	Cheltenham	Gloucestershire
United Kingdom	Novartis Investigative Site	Cheshire
United Kingdom	Novartis Investigative Site	Colchester
United Kingdom	Novartis Investigative Site	Coventry	London
United Kingdom	Novartis Investigative Site	Derby	London
United Kingdom	Novartis Investigative Site	Durham	County Durham
United Kingdom	Novartis Investigative Site	Frimley	Surrey
United Kingdom	Novartis Investigative Site	Guildford	Surrey
United Kingdom	Novartis Investigative Site	Hull	Lancashire
United Kingdom	Novartis Investigative Site	Inverness
United Kingdom	Novartis Investigative Site	Kent
United Kingdom	Novartis Investigative Site	Leeds
United Kingdom	Novartis Investigative Site	Leicester	Lancashire
United Kingdom	Novartis Investigative Site	Leytonstone	London
United Kingdom	Novartis Investigative Site	Liverpool
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Maidstone
United Kingdom	Novartis Investigative Site	Manchester
United Kingdom	Novartis Investigative Site	Merseyside
United Kingdom	Novartis Investigative Site	Merseyside
United Kingdom	Novartis Investigative Site	Middlesborough
United Kingdom	Novartis Investigative Site	Newport
United Kingdom	Novartis Investigative Site	Oxford	Oxfordshire
United Kingdom	Novartis Investigative Site	Portsmouth
United Kingdom	Novartis Investigative Site	Romford	Essex
United Kingdom	Novartis Investigative Site	Sheffield	South Yorkshire
United Kingdom	Novartis Investigative Site	Solihull	England
United Kingdom	Novartis Investigative Site	Southampton	England
United Kingdom	Novartis Investigative Site	Southend
United Kingdom	Novartis Investigative Site	Stoke-on-Trent	Staffordshire
United Kingdom	Novartis Investigative Site	Sunderland
United Kingdom	Novartis Investigative Site	Torquay	Devon,
United Kingdom	Novartis Investigative Site	Truro	Cornwall
United Kingdom	Novartis Investigative Site	Uxbridge
United Kingdom	Novartis Investigative Site	Wakefield	England
United Kingdom	Novartis Investigative Site	Wolverhampton
United Kingdom	Novartis Investigative Site	Worcester	UK
United Kingdom	Novartis Investigative Site	York
Venezuela	Novartis Investigative Site	Caracas
Venezuela	Novartis Investigative Site	Caracas, Piso 6, Ofic. 607
Venezuela	Novartis Investigative Site	Porlamar Local 02	Isla Margarita
Venezuela	Novartis Investigative Site	Santa Paula
Venezuela	Novartis Investigative Site	Torre Venezuela, Piso 1

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Visual Acuity (VA) and mean change in VA		3,6, and 12 months from the baseline visit, and annually thereafter	No
Primary	Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events		Defined time periods during study duration from FPFV until 30 days after LPLV	Yes
Primary	Mean visual acuity at quarterly intervals for the primary treated eye set		Quarterly intervals from baseline visit during study duration (5 years)	No
Secondary	Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)		From the time the patient signed the informed consent until 30 days after study discontinuation	Yes
Secondary	Number of ranibizumab injections administered per patient, per eye, and per person-year		annually	Yes
Secondary	"National Eye Institute Visual Functioning Questionnaire-25" change from baseline		annually	Yes
Secondary	Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination		Over time during study duration (5 years)	Yes
Secondary	Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores		Over time during study duration (5 years)	Yes