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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01318941




Registration number
NCT01318941
Ethics application status
Date submitted
17/03/2011
Date registered
21/03/2011
Date last updated
23/05/2016

Titles & IDs
Public title
Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting
Scientific title
LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes
Secondary ID [1] 0 0
CRFB002A2406
Universal Trial Number (UTN)
Trial acronym
LUMINOUS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion 0 0
Wet Age Related Macular Degeneration 0 0
Diabetic Macular Edema 0 0
Retinal Vein Occlusion 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab
Other interventions - Ranibizumab

Ranibizumab -


Treatment: Drugs: Ranibizumab


Other interventions: Ranibizumab
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean Visual Acuity (VA) and mean change in VA
Timepoint [1] 0 0
3,6, and 12 months from the baseline visit, and annually thereafter
Primary outcome [2] 0 0
Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
Timepoint [2] 0 0
Defined time periods during study duration from FPFV until 30 days after LPLV
Primary outcome [3] 0 0
Mean visual acuity at quarterly intervals for the primary treated eye set
Timepoint [3] 0 0
Quarterly intervals from baseline visit during study duration (5 years)
Secondary outcome [1] 0 0
Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
From the time the patient signed the informed consent until 30 days after study discontinuation
Secondary outcome [2] 0 0
Number of ranibizumab injections administered per patient, per eye, and per person-year
Timepoint [2] 0 0
annually
Secondary outcome [3] 0 0
"National Eye Institute Visual Functioning Questionnaire-25" change from baseline
Timepoint [3] 0 0
annually
Secondary outcome [4] 0 0
Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination
Timepoint [4] 0 0
Over time during study duration (5 years)
Secondary outcome [5] 0 0
Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores
Timepoint [5] 0 0
Over time during study duration (5 years)

Eligibility
Key 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/03/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2016
Sample size
Target
Accrual to date
Final
30490
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Chatswood
Recruitment hospital [2] 0 0
Novartis Investigative Site - Forster
Recruitment hospital [3] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [4] 0 0
Novartis Investigative Site - Liverpool
Recruitment hospital [5] 0 0
Novartis Investigative Site - North Ryde
Recruitment hospital [6] 0 0
Novartis Investigative Site - Parramatta
Recruitment hospital [7] 0 0
Novartis Investigative Site - Strathfield
Recruitment hospital [8] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [9] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [10] 0 0
Novartis Investigative Site - Brisbane
Recruitment hospital [11] 0 0
Novartis Investigative Site - South Brisbane
Recruitment hospital [12] 0 0
Novartis Investigative Site - Southport
Recruitment hospital [13] 0 0
Novartis Investigative Site - Adelaide
Recruitment hospital [14] 0 0
Novartis Investigative Site - North Adelaide
Recruitment hospital [15] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [16] 0 0
Novartis Investigative Site - South Launceston
Recruitment hospital [17] 0 0
Novartis Investigative Site - East Melbourne
Recruitment hospital [18] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [19] 0 0
Novartis Investigative Site - Glen Waverley
Recruitment hospital [20] 0 0
Novartis Investigative Site - Oakleigh
Recruitment postcode(s) [1] 0 0
2067 - Chatswood
Recruitment postcode(s) [2] 0 0
2428 - Forster
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2170 - Liverpool
Recruitment postcode(s) [5] 0 0
2109 - North Ryde
Recruitment postcode(s) [6] 0 0
2150 - Parramatta
Recruitment postcode(s) [7] 0 0
2135 - Strathfield
Recruitment postcode(s) [8] 0 0
2000 - Sydney
Recruitment postcode(s) [9] 0 0
Australia - Sydney
Recruitment postcode(s) [10] 0 0
2145 - Westmead
Recruitment postcode(s) [11] 0 0
4000 - Brisbane
Recruitment postcode(s) [12] 0 0
4101 - South Brisbane
Recruitment postcode(s) [13] 0 0
4125 - Southport
Recruitment postcode(s) [14] 0 0
5000 - Adelaide
Recruitment postcode(s) [15] 0 0
5006 - North Adelaide
Recruitment postcode(s) [16] 0 0
7000 - Hobart
Recruitment postcode(s) [17] 0 0
7249 - South Launceston
Recruitment postcode(s) [18] 0 0
3002 - East Melbourne
Recruitment postcode(s) [19] 0 0
3220 - Geelong
Recruitment postcode(s) [20] 0 0
VIC 3150 - Glen Waverley
Recruitment postcode(s) [21] 0 0
3166 - Oakleigh
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Caballito
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Argentina
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Ciudad de Buenos Aires,
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Argentina
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Concepción del Uruguay
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Argentina
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Córdoba
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Argentina
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Guaymallén, Mendoza
Country [8] 0 0
Argentina
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La Plata
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Argentina
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Rosario
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Argentina
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San Martin, Buenos Aires
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Austria
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Linz
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Austria
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Vienna
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Belgium
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Aalst
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Belgium
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Aarschot
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Belgium
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Bonheiden
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Belgium
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Bruxelles
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Belgium
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Dinant
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Belgium
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Edegem
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Belgium
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Gent
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Belgium
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Hasselt
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Belgium
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Leuven
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Belgium
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Mouscron
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Belgium
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Namur
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Belgium
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Nivelles
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Belgium
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Reet
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Belgium
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Yvoir
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Belgium
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Zottegem
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Brazil
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GO
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Brazil
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MG
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Brazil
State/province [30] 0 0
RJ
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Brazil
State/province [31] 0 0
RS
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Brazil
State/province [32] 0 0
SP
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Canada
State/province [33] 0 0
Alberta
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
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Canada
State/province [35] 0 0
New Brunswick
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Canada
State/province [36] 0 0
Nova Scotia
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Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
Canada
State/province [39] 0 0
Barrie
Country [40] 0 0
Canada
State/province [40] 0 0
Drummondville
Country [41] 0 0
Canada
State/province [41] 0 0
Hamilton
Country [42] 0 0
Chile
State/province [42] 0 0
Calama
Country [43] 0 0
China
State/province [43] 0 0
Beijing
Country [44] 0 0
China
State/province [44] 0 0
Guangdong
Country [45] 0 0
China
State/province [45] 0 0
Guizhou
Country [46] 0 0
China
State/province [46] 0 0
Hubei
Country [47] 0 0
China
State/province [47] 0 0
Shandong
Country [48] 0 0
China
State/province [48] 0 0
Tianjin
Country [49] 0 0
China
State/province [49] 0 0
Yunnan
Country [50] 0 0
China
State/province [50] 0 0
Changchun City
Country [51] 0 0
China
State/province [51] 0 0
Chongqing
Country [52] 0 0
China
State/province [52] 0 0
Fujian
Country [53] 0 0
China
State/province [53] 0 0
Shanghai
Country [54] 0 0
China
State/province [54] 0 0
Wulumuqi City
Country [55] 0 0
Colombia
State/province [55] 0 0
Atlantico
Country [56] 0 0
Colombia
State/province [56] 0 0
Quindío
Country [57] 0 0
Colombia
State/province [57] 0 0
Bogota
Country [58] 0 0
Colombia
State/province [58] 0 0
Bogotá
Country [59] 0 0
Colombia
State/province [59] 0 0
Cali
Country [60] 0 0
Colombia
State/province [60] 0 0
Yopal
Country [61] 0 0
Costa Rica
State/province [61] 0 0
San Jose
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Brno - Bohunice
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Hradec Kralove
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Olomouc
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Ostrava-Poruba
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Plzen
Country [67] 0 0
Czech Republic
State/province [67] 0 0
Praha 10
Country [68] 0 0
Czech Republic
State/province [68] 0 0
Praha
Country [69] 0 0
Czech Republic
State/province [69] 0 0
Ustri nad Labem
Country [70] 0 0
Dominican Republic
State/province [70] 0 0
Republica Dominicana
Country [71] 0 0
Ecuador
State/province [71] 0 0
Guayaquil
Country [72] 0 0
Egypt
State/province [72] 0 0
Cairo
Country [73] 0 0
Egypt
State/province [73] 0 0
Giza
Country [74] 0 0
France
State/province [74] 0 0
Bordeaux
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France
State/province [75] 0 0
Creteil
Country [76] 0 0
France
State/province [76] 0 0
Dijon
Country [77] 0 0
France
State/province [77] 0 0
Lyon CEDEX 04
Country [78] 0 0
France
State/province [78] 0 0
Melun
Country [79] 0 0
France
State/province [79] 0 0
Montargis
Country [80] 0 0
France
State/province [80] 0 0
Montauban
Country [81] 0 0
France
State/province [81] 0 0
Nantes Cedex 1
Country [82] 0 0
France
State/province [82] 0 0
Nice
Country [83] 0 0
France
State/province [83] 0 0
Paris cedex 10
Country [84] 0 0
France
State/province [84] 0 0
Paris Cedex 19
Country [85] 0 0
France
State/province [85] 0 0
Paris
Country [86] 0 0
France
State/province [86] 0 0
Poitiers
Country [87] 0 0
France
State/province [87] 0 0
Reims
Country [88] 0 0
France
State/province [88] 0 0
Toulouse Cedex 9
Country [89] 0 0
France
State/province [89] 0 0
Vannes
Country [90] 0 0
Germany
State/province [90] 0 0
Augsburg
Country [91] 0 0
Germany
State/province [91] 0 0
Berlin
Country [92] 0 0
Germany
State/province [92] 0 0
Bonn
Country [93] 0 0
Germany
State/province [93] 0 0
Dannenberg
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Germany
State/province [94] 0 0
Hamburg
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Germany
State/province [95] 0 0
Ingolstadt
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Germany
State/province [96] 0 0
Koeln
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Germany
State/province [97] 0 0
Luedenscheid
Country [98] 0 0
Germany
State/province [98] 0 0
Muenster
Country [99] 0 0
Germany
State/province [99] 0 0
Neu-Ulm
Country [100] 0 0
Germany
State/province [100] 0 0
Osnabrück
Country [101] 0 0
Germany
State/province [101] 0 0
Regensburg
Country [102] 0 0
Germany
State/province [102] 0 0
Rothenburg
Country [103] 0 0
Germany
State/province [103] 0 0
Schriesheim
Country [104] 0 0
Germany
State/province [104] 0 0
Tuebingen
Country [105] 0 0
Germany
State/province [105] 0 0
Tönisvorst
Country [106] 0 0
Greece
State/province [106] 0 0
GR
Country [107] 0 0
Greece
State/province [107] 0 0
Alexandroupolis
Country [108] 0 0
Greece
State/province [108] 0 0
Athens
Country [109] 0 0
Greece
State/province [109] 0 0
Lamia, Phthiotis
Country [110] 0 0
Guatemala
State/province [110] 0 0
Guatemala City
Country [111] 0 0
Hong Kong
State/province [111] 0 0
Kowloon
Country [112] 0 0
Hungary
State/province [112] 0 0
Budapest
Country [113] 0 0
Hungary
State/province [113] 0 0
Debrecen
Country [114] 0 0
Hungary
State/province [114] 0 0
Pecs
Country [115] 0 0
Hungary
State/province [115] 0 0
Szeged
Country [116] 0 0
India
State/province [116] 0 0
Bhudaneswar
Country [117] 0 0
India
State/province [117] 0 0
Tamil Nadu
Country [118] 0 0
India
State/province [118] 0 0
Telangana
Country [119] 0 0
India
State/province [119] 0 0
Ahmedabad
Country [120] 0 0
India
State/province [120] 0 0
New Delhi
Country [121] 0 0
Ireland
State/province [121] 0 0
Dublin 7
Country [122] 0 0
Ireland
State/province [122] 0 0
Dublin
Country [123] 0 0
Ireland
State/province [123] 0 0
Waterford
Country [124] 0 0
Israel
State/province [124] 0 0
Haifa
Country [125] 0 0
Israel
State/province [125] 0 0
Petach Tikva
Country [126] 0 0
Israel
State/province [126] 0 0
Tel Aviv
Country [127] 0 0
Italy
State/province [127] 0 0
BA
Country [128] 0 0
Italy
State/province [128] 0 0
CA
Country [129] 0 0
Italy
State/province [129] 0 0
GE
Country [130] 0 0
Italy
State/province [130] 0 0
Alessandria
Country [131] 0 0
Italy
State/province [131] 0 0
Belluno
Country [132] 0 0
Italy
State/province [132] 0 0
Brescia
Country [133] 0 0
Italy
State/province [133] 0 0
Pisa
Country [134] 0 0
Italy
State/province [134] 0 0
Reggio Calabria
Country [135] 0 0
Italy
State/province [135] 0 0
Roma
Country [136] 0 0
Japan
State/province [136] 0 0
Aichi
Country [137] 0 0
Japan
State/province [137] 0 0
Chiba
Country [138] 0 0
Japan
State/province [138] 0 0
Ehime
Country [139] 0 0
Japan
State/province [139] 0 0
Fukui
Country [140] 0 0
Japan
State/province [140] 0 0
Fukuoka
Country [141] 0 0
Japan
State/province [141] 0 0
Fukushima
Country [142] 0 0
Japan
State/province [142] 0 0
Gunma
Country [143] 0 0
Japan
State/province [143] 0 0
Hiroshima
Country [144] 0 0
Japan
State/province [144] 0 0
Hokkaido
Country [145] 0 0
Japan
State/province [145] 0 0
Hokkido
Country [146] 0 0
Japan
State/province [146] 0 0
Hyogo
Country [147] 0 0
Japan
State/province [147] 0 0
Ibaraki
Country [148] 0 0
Japan
State/province [148] 0 0
Ishikawa
Country [149] 0 0
Japan
State/province [149] 0 0
Kagawa
Country [150] 0 0
Japan
State/province [150] 0 0
Kanagawa
Country [151] 0 0
Japan
State/province [151] 0 0
Kangawa
Country [152] 0 0
Japan
State/province [152] 0 0
Kyoto
Country [153] 0 0
Japan
State/province [153] 0 0
Mie
Country [154] 0 0
Japan
State/province [154] 0 0
Miyagi
Country [155] 0 0
Japan
State/province [155] 0 0
Miyazakiken
Country [156] 0 0
Japan
State/province [156] 0 0
Miyazaki
Country [157] 0 0
Japan
State/province [157] 0 0
Nagano
Country [158] 0 0
Japan
State/province [158] 0 0
Nagasaki
Country [159] 0 0
Japan
State/province [159] 0 0
Nara
Country [160] 0 0
Japan
State/province [160] 0 0
Osaka
Country [161] 0 0
Japan
State/province [161] 0 0
Saitama
Country [162] 0 0
Japan
State/province [162] 0 0
Shizuoka
Country [163] 0 0
Japan
State/province [163] 0 0
Tochigi
Country [164] 0 0
Japan
State/province [164] 0 0
Tokushima
Country [165] 0 0
Japan
State/province [165] 0 0
Tokyo
Country [166] 0 0
Japan
State/province [166] 0 0
Toyama
Country [167] 0 0
Japan
State/province [167] 0 0
Yamanashi
Country [168] 0 0
Japan
State/province [168] 0 0
Akita
Country [169] 0 0
Japan
State/province [169] 0 0
Aomori
Country [170] 0 0
Japan
State/province [170] 0 0
Chiyoda-ku
Country [171] 0 0
Japan
State/province [171] 0 0
Gifu
Country [172] 0 0
Japan
State/province [172] 0 0
Hamamatsu-shi
Country [173] 0 0
Japan
State/province [173] 0 0
Kagoshima
Country [174] 0 0
Japan
State/province [174] 0 0
Kakogawa-shi
Country [175] 0 0
Japan
State/province [175] 0 0
Kawasaki-shi
Country [176] 0 0
Japan
State/province [176] 0 0
Kitami-shi
Country [177] 0 0
Japan
State/province [177] 0 0
Koriyama-shi
Country [178] 0 0
Japan
State/province [178] 0 0
Kouchi
Country [179] 0 0
Japan
State/province [179] 0 0
Kyoto-shi
Country [180] 0 0
Japan
State/province [180] 0 0
Nagasaki-shi
Country [181] 0 0
Japan
State/province [181] 0 0
Nantan-shi
Country [182] 0 0
Japan
State/province [182] 0 0
Otsu-shi
Country [183] 0 0
Japan
State/province [183] 0 0
Saitama-ken
Country [184] 0 0
Japan
State/province [184] 0 0
Sanjo-shi
Country [185] 0 0
Japan
State/province [185] 0 0
Shizuoka-shi
Country [186] 0 0
Japan
State/province [186] 0 0
Shunan-shi
Country [187] 0 0
Japan
State/province [187] 0 0
Toyohashi-shi
Country [188] 0 0
Japan
State/province [188] 0 0
Wakayama
Country [189] 0 0
Japan
State/province [189] 0 0
Yamagata
Country [190] 0 0
Korea, Republic of
State/province [190] 0 0
Gyeonggi-do
Country [191] 0 0
Korea, Republic of
State/province [191] 0 0
Gyeonggi
Country [192] 0 0
Korea, Republic of
State/province [192] 0 0
Korea
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Korea, Republic of
State/province [193] 0 0
Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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Pusan
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Korea, Republic of
State/province [196] 0 0
Seoul
Country [197] 0 0
Korea, Republic of
State/province [197] 0 0
Taegu
Country [198] 0 0
Malaysia
State/province [198] 0 0
Selangor
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Malaysia
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Kuala Lumpur
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Mexico
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CP
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Mexico
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Distrito Federal
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Mexico
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Nuevo León
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Mexico
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Yucatán
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Netherlands
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Almere
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Netherlands
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Amsterdam
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Netherlands
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Tilburg
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Panama
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Panamá
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Peru
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Lima
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Poland
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Bydgoszcz
Country [210] 0 0
Poland
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Chojnice
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Poland
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Chorzow
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Poland
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Gdansk
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Poland
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Gda¿sk
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Poland
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Kalisz
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Poland
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01318941
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01318941