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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Ranibizumab -

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
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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
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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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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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Belgium
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Nivelles
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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
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RJ
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Brazil
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RS
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Brazil
State/province [32] 0 0
SP
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Canada
State/province [33] 0 0
Alberta
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British Columbia
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Canada
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New Brunswick
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Nova Scotia
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Ontario
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Quebec
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Barrie
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Drummondville
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Canada
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Hamilton
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Chile
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Calama
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Beijing
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China
State/province [44] 0 0
Guangdong
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China
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Guizhou
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Hubei
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Tianjin
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Changchun City
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Chongqing
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China
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Fujian
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Shanghai
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China
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Wulumuqi City
Country [55] 0 0
Colombia
State/province [55] 0 0
Atlantico
Country [56] 0 0
Colombia
State/province [56] 0 0
Quindío
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Colombia
State/province [57] 0 0
Bogota
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Colombia
State/province [58] 0 0
Bogotá
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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
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Czech Republic
State/province [62] 0 0
Brno - Bohunice
Country [63] 0 0
Czech Republic
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Hradec Kralove
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Czech Republic
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Olomouc
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Czech Republic
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Ostrava-Poruba
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Czech Republic
State/province [66] 0 0
Plzen
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Czech Republic
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Praha 10
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Czech Republic
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Praha
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Czech Republic
State/province [69] 0 0
Ustri nad Labem
Country [70] 0 0
Dominican Republic
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Republica Dominicana
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Ecuador
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Guayaquil
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Egypt
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Cairo
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Egypt
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Giza
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France
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Bordeaux
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Creteil
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Dijon
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Lyon CEDEX 04
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Melun
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Montargis
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Montauban
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Nantes Cedex 1
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France
State/province [82] 0 0
Nice
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Paris cedex 10
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France
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Paris Cedex 19
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France
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Paris
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France
State/province [86] 0 0
Poitiers
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France
State/province [87] 0 0
Reims
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France
State/province [88] 0 0
Toulouse Cedex 9
Country [89] 0 0
France
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Vannes
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Germany
State/province [90] 0 0
Augsburg
Country [91] 0 0
Germany
State/province [91] 0 0
Berlin
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Germany
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Bonn
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Germany
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Dannenberg
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Germany
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Hamburg
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Germany
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Ingolstadt
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Germany
State/province [96] 0 0
Koeln
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Germany
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Luedenscheid
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Germany
State/province [98] 0 0
Muenster
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Germany
State/province [99] 0 0
Neu-Ulm
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Germany
State/province [100] 0 0
Osnabrück
Country [101] 0 0
Germany
State/province [101] 0 0
Regensburg
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Germany
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Rothenburg
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Germany
State/province [103] 0 0
Schriesheim
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Germany
State/province [104] 0 0
Tuebingen
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Germany
State/province [105] 0 0
Tönisvorst
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Greece
State/province [106] 0 0
GR
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Greece
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Alexandroupolis
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Greece
State/province [108] 0 0
Athens
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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
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Hungary
State/province [115] 0 0
Szeged
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India
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Bhudaneswar
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India
State/province [117] 0 0
Tamil Nadu
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India
State/province [118] 0 0
Telangana
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India
State/province [119] 0 0
Ahmedabad
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India
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New Delhi
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Ireland
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Dublin 7
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Ireland
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Dublin
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Ireland
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Waterford
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Israel
State/province [124] 0 0
Haifa
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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
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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
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Japan
State/province [150] 0 0
Kanagawa
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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
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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
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Japan
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Tochigi
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Japan
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Tokushima
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Japan
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Tokyo
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Japan
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Toyama
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Japan
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Yamanashi
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Japan
State/province [168] 0 0
Akita
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Japan
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Aomori
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Japan
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Chiyoda-ku
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Japan
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Gifu
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Japan
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Hamamatsu-shi
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Japan
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Kagoshima
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Japan
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Kakogawa-shi
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Japan
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Kawasaki-shi
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Japan
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Kitami-shi
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Japan
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Japan
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Kouchi
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Japan
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Japan
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Japan
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Japan
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Otsu-shi
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Japan
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Japan
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Japan
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Japan
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Shunan-shi
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Japan
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Toyohashi-shi
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Japan
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Japan
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Yamagata
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Gyeonggi-do
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Korea, Republic of
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Korea, Republic of
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Korea
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Korea, Republic of
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Seoul
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Korea, Republic of
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Taegu
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Malaysia
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Selangor
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Malaysia
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CP
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Distrito Federal
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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
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Chojnice
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Chorzow
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Gdansk
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Gda¿sk
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Kalisz
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Kielce
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Krakow
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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/study/NCT01318941
Trial related presentations / publications
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.
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.
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.
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.
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.
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/study/NCT01318941