Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein OcclusionLUMINOUSNCT01318941

Observe the Effectiveness and Safety of Ranibizumab in Real Life Setting

An observational study of Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion and Wet Age Related Macular Degeneration, run by Novartis Pharmaceuticals at 463 sites in 43 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, Wet Age Related Macular Degeneration, Diabetic Macular Edema
What is being tested?: Ranibizumab
How many people: 30,490 participants
Where: 463 sitesin 43 countries
Study dates: Mar 2011to Apr 2016
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Outpatient ophthalmology Clinics

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

463 sites in 43 countries.

Country

City, postcode or hospital

463 sites in 43 countries

Japan91 sites

Novartis Investigative Site
Akita
Novartis Investigative Site
Amagasaki, Hyōgo, 660-8550
Novartis Investigative Site
Aomori, Aomori, 030-8553
Novartis Investigative Site
Ashigarakami-gun, Kanagawa
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-8431
Novartis Investigative Site
Chiyoda-ku, Tokyo, 101-8309
Novartis Investigative Site
Chiyoda-ku, 101-0062
Novartis Investigative Site
Chūō, Yamanashi, 409-3898
Novartis Investigative Site
Ehime
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Fukuoka, Fukuoka, 814-0180
Novartis Investigative Site
Fukushima, Fukushima, 960-1295
Novartis Investigative Site
Gifu
Novartis Investigative Site
Hamamatsu, Shizuoka, 430-8558
Novartis Investigative Site
Hamamatsu, 430-0903
Novartis Investigative Site
Hirakata, Osaka, 573-1191
Novartis Investigative Site
Hiroshima, Hiroshima, 734-8551
Novartis Investigative Site
Hokkaido, 080-0805
Novartis Investigative Site
Hokkaido
Novartis Investigative Site
Hyōgo
Novartis Investigative Site
Imizu-shi, Toyama, 939-0243
Novartis Investigative Site
Inashiki-gun, Ibaraki, 300-0395
Novartis Investigative Site
Ishikawa
Novartis Investigative Site
Izunokuni, Shizuoka, 410-2295
Novartis Investigative Site
Kagoshima, 890-0046
Novartis Investigative Site
Kagoshima
Novartis Investigative Site
Kakogawa-shi, 675-8611
Novartis Investigative Site
Kanagawa
Novartis Investigative Site
Kanazawa, Ishikawa-ken, 920-8641
Novartis Investigative Site
Kashihara, Nara, 634-8522
Novartis Investigative Site
Kawasaki-shi, 211-0053
Novartis Investigative Site
Kita-gun, Kagawa-ken, 761-0793
Novartis Investigative Site
Kitakyushu, Fukuoka, 807-8556
Novartis Investigative Site
Kitami-shi, 090-8666
Novartis Investigative Site
Kobe, Hyōgo, 657-0068
Novartis Investigative Site
Koriyama-shi, 963-8585
Novartis Investigative Site
Kouchi, 783-8505
Novartis Investigative Site
Kyoto, Kyoto, 606-8507
Novartis Investigative Site
Kyoto, 604-0837
Novartis Investigative Site
Maebashi, Gunma, 371-8511
Novartis Investigative Site
Matsuyama, Ehime, 790-8524
Novartis Investigative Site
Mitaka, Tokyo, 181-8611
Novartis Investigative Site
Miyagi, 980-8574
Novartis Investigative Site
Miyakonojō, Miyazaki
Novartis Investigative Site
Miyazaki, Miyazaki, 889-1692
Novartis Investigative Site
Nagakute, Aichi-ken, 480-1195
Novartis Investigative Site
Nagano
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8501
Novartis Investigative Site
Nagasaki, 852-8511
Novartis Investigative Site
Nagoya, Aichi-ken, 462-0825
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Nagoya, Aichi-ken
Novartis Investigative Site
Nantan-shi, 629-0392
Novartis Investigative Site
Nerima-ku, Tokyo
Novartis Investigative Site
Nishinomiya, Hyōgo, 663-8501
Novartis Investigative Site
Osaka, Osaka, 545-8586
Novartis Investigative Site
Osaka
Novartis Investigative Site
Ōtsu, 520-2192
Novartis Investigative Site
Saitama, Saitama, 330-8503
Novartis Investigative Site
Saitama, Saitama, 338-8553
Novartis Investigative Site
Saitama-ken, 336-0963
Novartis Investigative Site
Sakura, Chiba, 285-8741
Novartis Investigative Site
Sanjo-shi, 955-0852
Novartis Investigative Site
Sapporo, Hokkaido, 060-8543
Novartis Investigative Site
Sapporo, Hokkido
Novartis Investigative Site
Sayama, Osaka, 589-8511
Novartis Investigative Site
Sendai, Miyagi, 981-8563
Novartis Investigative Site
Shimotsuka-gun, Tochigi, 321-0293
Novartis Investigative Site
Shinjuku-ku, Tokyo, 160-0023
Novartis Investigative Site
Shinjuku-ku, Tokyo, 162-8666
Novartis Investigative Site
Shizuoka, Shizuoka, 422-8527
Novartis Investigative Site
Shizuoka, 420-0841
Novartis Investigative Site
Shunan-shi, 745-0017
Novartis Investigative Site
Suwa, Nagano, 392-8510
Novartis Investigative Site
Tochigi
Novartis Investigative Site
Tokushima, Tokushima, 770-8503
Novartis Investigative Site
Tokyo, 153-8515
Novartis Investigative Site
Tokyo
Novartis Investigative Site
Toyama, Toyama, 930-0194
Novartis Investigative Site
Toyoake, Aichi-ken, 470-1192
Novartis Investigative Site
Toyohashi, 441-8106
Novartis Investigative Site
Tsu, Mie-ken, 514-8507
Novartis Investigative Site
Tsukuba, Ibaraki, 305-8576
Novartis Investigative Site
Urayasu, Tokyo, 279-0021
Novartis Investigative Site
Wakayama, 640-8558
Novartis Investigative Site
Yamagata, Yamagata, 990-9585
Novartis Investigative Site
Yamagata
Novartis Investigative Site
Yokohama, Kanagawa, 232-0024
Novartis Investigative Site
Yokohama, Kangawa
Novartis Investigative Site
Yokosuka, Kanagawa, 238-8558
Novartis Investigative Site
Yoshida-gun, Fukui, 910-1193

Other trials in Japan

United Kingdom49 sites

Novartis Investigative Site
Bedford, MK429DJ
Novartis Investigative Site
Belfast, Essex, BT12 6BA
Novartis Investigative Site
Birmingham, B18 7QU
Novartis Investigative Site
Blackburn, Lancashire, BB2 3HH
Novartis Investigative Site
Bolton, England, BL4 0JR
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ
Novartis Investigative Site
Bristol, BS1 2LX
Novartis Investigative Site
Cardiff, CF14 4XN
Novartis Investigative Site
Cheltenham, Gloucestershire, GL53 7AN
Novartis Investigative Site
Cheshire, CW1 4QJ
Novartis Investigative Site
Colchester, CO3 3NB
Novartis Investigative Site
Coventry, London, CV2 2DX
Novartis Investigative Site
Derby, London, DE22 3NE
Novartis Investigative Site
Durham, County Durham, DH1 5TW
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ
Novartis Investigative Site
Guildford, Surrey, GU2 7XX
Novartis Investigative Site
Hull, Lancashire, HU3 2JZ
Novartis Investigative Site
Inverness, IV2 3UJ
Novartis Investigative Site
Kent, CT1 3NG
Novartis Investigative Site
Leeds, LS9 7TF
Novartis Investigative Site
Leicester, Lancashire, LE1 5WW
Novartis Investigative Site
Leytonstone, London, E11 1NR
Novartis Investigative Site
Liverpool, L9 7AL
Novartis Investigative Site
London, United Kingdom, EC1V 2PD
Novartis Investigative Site
London, NW1 5QH
Novartis Investigative Site
London, NW3 2QG
Novartis Investigative Site
London, SE5 9RS
Novartis Investigative Site
Maidstone, ME16 9QQ
Novartis Investigative Site
Manchester, M13 9WL
Novartis Investigative Site
Merseyside, CH49 5PE
Novartis Investigative Site
Merseyside, L7 8PX
Novartis Investigative Site
Middlesbrough, TS4 3BW
Novartis Investigative Site
Newport, P030 5TG
Novartis Investigative Site
Oxford, Oxfordshire, OX3 9DU
Novartis Investigative Site
Portsmouth, PO6 3LY
Novartis Investigative Site
Romford, Essex, RM7 0AG
Novartis Investigative Site
Sheffield, South Yorkshire, S10 2JF
Novartis Investigative Site
Solihull, England, B91 2JL
Novartis Investigative Site
Southampton, England, SO16 6YD
Novartis Investigative Site
Southend, SS0 0RY
Novartis Investigative Site
Stoke-on-Trent, Staffordshire, ST4 7LN
Novartis Investigative Site
Sunderland, SR2 9HP
Novartis Investigative Site
Torquay, Devon,, TQ2 7AA
Novartis Investigative Site
Truro, Cornwall, TR1 3LJ
Novartis Investigative Site
Uxbridge, UB8 3NN
Novartis Investigative Site
Wakefield, England, WF1 3JS
Novartis Investigative Site
Wolverhampton, WV10 0QP
Novartis Investigative Site
Worcester, UK, WR5 1DD
Novartis Investigative Site
York, YO31 8HE

Other trials in United Kingdom

Spain22 sites

Novartis Investigative Site
Barcelona, Catalonia, 08025
Novartis Investigative Site
Barcelona, 08025
Novartis Investigative Site
Burgos, 09006
Novartis Investigative Site
Granollers, 08402
Novartis Investigative Site
León, Castille and León, 24071
Novartis Investigative Site
Logroño, Hospital La Rioja Provincia, 26001
Novartis Investigative Site
Lugo, Galicia, 27003
Novartis Investigative Site
Madrid, 28008
Novartis Investigative Site
Madrid, 28010
Novartis Investigative Site
Madrid, 28040
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28805
Novartis Investigative Site
Málaga, Andalusia, 29010
Novartis Investigative Site
Murcia, Murcia, 30003
Novartis Investigative Site
Salamanca, Castille and León, 32007
Novartis Investigative Site
Sant Cugat del Vallès, Catalonia, 08190
Novartis Investigative Site
Tarragona, Catalonia, 43005
Novartis Investigative Site
Valencia, Valencia, 46015
Novartis Investigative Site
Valencia, Valencia, 46026
Novartis Investigative Site
Valladolid, Castille and León, 47011
Novartis Investigative Site
Zaragoza, Zaragoza, 50009
Novartis Investigative Site
Zaragoza, 50009

Other trials in Spain

Australia21 sites

Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
Brisbane, Queensland, 4000
Novartis Investigative Site
Chatswood, New South Wales, 2067
Novartis Investigative Site
East Melbourne, Victoria, 3002
Novartis Investigative Site
Forster, New South Wales, 2428
Novartis Investigative Site
Geelong, Victoria, 3220
Novartis Investigative Site
Glen Waverley, Victoria, VIC 3150
Novartis Investigative Site
Hobart, Tasmania, 7000
Novartis Investigative Site
Kogarah, New South Wales, 2217
Novartis Investigative Site
Liverpool, New South Wales, 2170
Novartis Investigative Site
North Adelaide, South Australia, 5006
Novartis Investigative Site
North Ryde, New South Wales, 2109
Novartis Investigative Site
Oakleigh, Victoria, 3166
Novartis Investigative Site
Parramatta, New South Wales, 2150
Novartis Investigative Site
South Brisbane, Queensland, 4101
Novartis Investigative Site
South Launceston, Tasmania, 7249
Novartis Investigative Site
Southport, Queensland, 4125
Novartis Investigative Site
Strathfield, New South Wales, 2135
Novartis Investigative Site
Sydney, New South Wales, 2000
Novartis Investigative Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Westmead, New South Wales, 2145

Other trials in Australia

Russia20 sites

Novartis Investigative Site
Cheboksary, 428028
Novartis Investigative Site
Chelyabinsk, 454000
Novartis Investigative Site
Chita, 672038
Novartis Investigative Site
Irkutsk, 664033
Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Khabarovsk, 680033
Novartis Investigative Site
Krasnodar, 350012
Novartis Investigative Site
Moscow, 105229
Novartis Investigative Site
Moscow, 10562
Novartis Investigative Site
Moscow, 119021
Novartis Investigative Site
Novosibirsk, 630096
Novartis Investigative Site
Penza, 440026
Novartis Investigative Site
Saint Petersburg, Russia
Novartis Investigative Site
Samara, 443079
Novartis Investigative Site
Saratov, 410028
Novartis Investigative Site
Surgut, 121359
Novartis Investigative Site
Tambov, 392000
Novartis Investigative Site
Tyumen, 625048
Novartis Investigative Site
Ufa, 450077
Novartis Investigative Site
Yakutsk, 677000

Other trials in Russia

China19 sites

Novartis Investigative Site
Beijing, Beijing Municipality, 100083
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, Beijing Municipality
Novartis Investigative Site
Beijing, 100034
Novartis Investigative Site
Beijing, 100730
Novartis Investigative Site
Beijing
Novartis Investigative Site
Changchun, 130041
Novartis Investigative Site
Chongqing, 400038
Novartis Investigative Site
Fujian, 361001
Novartis Investigative Site
Guangzhou, Guangdong, 510060
Novartis Investigative Site
Guiyang, Guizhou, 550004
Novartis Investigative Site
Jinan, Shandong, 250001
Novartis Investigative Site
Kunming, Yunnan, 650021
Novartis Investigative Site
Shanghai, 200080
Novartis Investigative Site
Shanghai, 200092
Novartis Investigative Site
Shanghai
Novartis Investigative Site
Tianjin, Tianjin Municipality, 300020
Novartis Investigative Site
Ürümqi, 830000
Novartis Investigative Site
Wuhan, Hubei, 430060

Other trials in China

Canada18 sites

Novartis Investigative Site
Barrie, ON L4M 4S
Novartis Investigative Site
Boisbriand, Quebec, J7H 1S6
Novartis Investigative Site
Brampton, Ontario, L6Y 0P6
Novartis Investigative Site
Calgary, Alberta, T2H0C8
Novartis Investigative Site
Downsview, Ontario, M5N 2V6
Novartis Investigative Site
Drummondville, J2B 5L4
Novartis Investigative Site
East Brockville, Ontario, K6V 0V6
Novartis Investigative Site
Halifax, Nova Scotia, B3H 2A5
Novartis Investigative Site
Hamilton, L9C 5R3
Novartis Investigative Site
London, Ontario, N6A 4G5
Novartis Investigative Site
Miramichi, New Brunswick, E1V 1N9
Novartis Investigative Site
Ontario, M1E 4A7
Novartis Investigative Site
Ottawa, Ontario, K1H 8L6
Novartis Investigative Site
Ottawa, Ontario, K1Z 8R2
Novartis Investigative Site
Scarborough Village, Ontario, M1R 3A6
Novartis Investigative Site
Toronto, Ontario, M5T 2S8
Novartis Investigative Site
Vaughan, Ontario, L4K 0C5
Novartis Investigative Site
Victoria, British Columbia, V8V 4X3

Other trials in Canada

Germany18 sites

Novartis Investigative Site
Augsburg, 86156
Novartis Investigative Site
Berlin, 10367
Novartis Investigative Site
Berlin, 10707
Novartis Investigative Site
Bonn, D-53105
Novartis Investigative Site
Cologne, 50924
Novartis Investigative Site
Dannenberg, 29451
Novartis Investigative Site
Hamburg, 22587
Novartis Investigative Site
Ingolstadt, 85049
Novartis Investigative Site
Lüdenscheid, 58515
Novartis Investigative Site
Münster, 48145
Novartis Investigative Site
Münster, 48149
Novartis Investigative Site
Neu-Ulm, 89231
Novartis Investigative Site
Osnabrück, 49076
Novartis Investigative Site
Regensburg, 93 047
Novartis Investigative Site
Rothenburg, 91541
Novartis Investigative Site
Schriesheim, 69198
Novartis Investigative Site
Tönisvorst, 47918
Novartis Investigative Site
Tübingen, 72076

Other trials in Germany

Argentina17 sites

Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, 1121
Novartis Investigative Site
Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, CP1425
Novartis Investigative Site
Caballito, C1437AVJ
Novartis Investigative Site
Ciudad de Buenos Aires,, Argentina
Novartis Investigative Site
Concepción del Uruguay, Argentina
Novartis Investigative Site
Córdoba, Argentina, CP 5000
Novartis Investigative Site
Guaymallén, Mendoza, Argentina
Novartis Investigative Site
La Plata
Novartis Investigative Site
Lanus, Buenos Aires, B1824ABE
Novartis Investigative Site
Mar del Plata, Buenos Aires
Novartis Investigative Site
Rosario, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province
Novartis Investigative Site
San Martin, Buenos Aires, Argentina
Novartis Investigative Site
Santa Fe, Argentina
Novartis Investigative Site
Santa Fe, Argentina

Other trials in Argentina

France17 sites

Novartis Investigative Site
Bordeaux, 33 000
Novartis Investigative Site
Créteil, 94000
Novartis Investigative Site
Dijon, 21034
Novartis Investigative Site
Lyon, 69317
Novartis Investigative Site
Melun, 77000
Novartis Investigative Site
Montargis, 45200
Novartis Investigative Site
Montauban, 82000
Novartis Investigative Site
Nantes, 44093
Novartis Investigative Site
Nice, 06200
Novartis Investigative Site
Paris, 75006
Novartis Investigative Site
Paris, 75010
Novartis Investigative Site
Paris, 75015
Novartis Investigative Site
Paris, 75940
Novartis Investigative Site
Poitiers, France, 86000
Novartis Investigative Site
Reims, 51100
Novartis Investigative Site
Toulouse, 31059
Novartis Investigative Site
Vannes, 56000

Other trials in France

Belgium15 sites

Novartis Investigative Site
Aalst, Belgium, 9300
Novartis Investigative Site
Aarschot, Belgium, 3200
Novartis Investigative Site
Bonheiden, 2820
Novartis Investigative Site
Brussels, 1070
Novartis Investigative Site
Dinant, 5500
Novartis Investigative Site
Edegem, 2650
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Hasselt, 3500
Novartis Investigative Site
Leuven, 3000
Novartis Investigative Site
Mouscron, 7700
Novartis Investigative Site
Namur, 5000
Novartis Investigative Site
Nivelles, 1400
Novartis Investigative Site
Reet, 2840
Novartis Investigative Site
Yvoir, 5530
Novartis Investigative Site
Zottegem, 9620

Other trials in Belgium

Poland15 sites

Novartis Investigative Site
Bydgoszcz, 85-681
Novartis Investigative Site
Chojnice, 89-600
Novartis Investigative Site
Chorzów, 40-064
Novartis Investigative Site
Gda¿sk, 80-402
Novartis Investigative Site
Gdansk, 80-147
Novartis Investigative Site
Kalisz, 62 800
Novartis Investigative Site
Kielce, 25-514
Novartis Investigative Site
Krakow, 31-826
Novartis Investigative Site
Lodz, 93 357
Novartis Investigative Site
Olsztyn, 10-424
Novartis Investigative Site
Poznan, 61-693
Novartis Investigative Site
Wałbrzych, 58-300
Novartis Investigative Site
Warsaw, 02-097
Novartis Investigative Site
Warsaw, 04-141
Novartis Investigative Site
Wołomin, 05-200

Other trials in Poland

South Korea13 sites

Novartis Investigative Site
Busan, 612-896
Novartis Investigative Site
Daegu, 705-703
Novartis Investigative Site
Pusan, 602-739
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
Novartis Investigative Site
Seoul, Korea, 05505
Novartis Investigative Site
Seoul, Korea, 110 744
Novartis Investigative Site
Seoul, 120-752
Novartis Investigative Site
Seoul, 130-872
Novartis Investigative Site
Seoul, 137-701
Novartis Investigative Site
Seoul, 150-950
Novartis Investigative Site
Seoul
Novartis Investigative Site
Suwon, Gyeonggi-do, 443-721
Novartis Investigative Site
Taegu, 700 - 721

Other trials in South Korea

Slovakia12 sites

Novartis Investigative Site
Banksa Bystrica, Slovak Republic, 974 17
Novartis Investigative Site
Bratislava, Slovakia, 833 01
Novartis Investigative Site
Bratislava, 813 69
Novartis Investigative Site
Bratislava, 851 07
Novartis Investigative Site
Ljubljana, 1000
Novartis Investigative Site
Nové Zámky, Slovakia, 940 34
Novartis Investigative Site
Poprad, 058 01
Novartis Investigative Site
Ružomberok, 034 01
Novartis Investigative Site
Trebišov, Slovak Republic, 075 01
Novartis Investigative Site
Trenčín, SK-91171
Novartis Investigative Site
Žilina, Slovakia, 01207
Novartis Investigative Site
Zvolen, Slovakia, 960 01

Other trials in Slovakia

Greece11 sites

Novartis Investigative Site
Alexandroupoli, Greece, 68100
Novartis Investigative Site
Athens, Greece, 11525
Novartis Investigative Site
Athens, Greece, 176 73
Novartis Investigative Site
Athens, GR, 106 72
Novartis Investigative Site
Athens, 10436
Novartis Investigative Site
Heraklion - Crete, GR, 711 10
Novartis Investigative Site
Lamia, Phthiotis, 35100
Novartis Investigative Site
Larissa, GR, 411 10
Novartis Investigative Site
Patra - RIO, GR, 265 04
Novartis Investigative Site
Rethymno, GR, 741 00
Novartis Investigative Site
Thessaloniki, GR, 546 29

Other trials in Greece

Italy10 sites

Novartis Investigative Site
Acquaviva delle Fonti, BA, 70021
Novartis Investigative Site
Alessandria
Novartis Investigative Site
Belluno, 32100
Novartis Investigative Site
Brescia, 25123
Novartis Investigative Site
Cagliari, CA, 09124
Novartis Investigative Site
Genova, GE, 16132
Novartis Investigative Site
Pisa, 56124
Novartis Investigative Site
Reggio Calabria, 89100
Novartis Investigative Site
Roma, 00161
Novartis Investigative Site
Roma, 00168

Other trials in Italy

Czechia9 sites

Novartis Investigative Site
Brno-Bohunice, Czech Republic, 625 00
Novartis Investigative Site
Hradec Králové, 500 05
Novartis Investigative Site
Olomouc, 775 20
Novartis Investigative Site
Ostrava-Poruba, 708 52
Novartis Investigative Site
Pilsen, 304 60
Novartis Investigative Site
Prague, 100 34
Novartis Investigative Site
Prague, 12808
Novartis Investigative Site
Prague, 16902
Novartis Investigative Site
Ustri Nad Labem, 401 13

Other trials in Czechia

Portugal7 sites

Novartis Investigative Site
Aveiro, 3814-501
Novartis Investigative Site
Coimbra, Portugal, 3000-354
Novartis Investigative Site
Coimbra, Portugal, 3030-163
Novartis Investigative Site
Leiria, 2410-104
Novartis Investigative Site
Lisbon, 1500
Novartis Investigative Site
Matosinhos Municipality, 4454-509
Novartis Investigative Site
Santa Maria da Feira, 4520-211

Other trials in Portugal

Brazil6 sites

Novartis Investigative Site
Belo Horizonte, Minas Gerais, 30150-270
Novartis Investigative Site
Campinas, São Paulo, 13092-132
Novartis Investigative Site
Goiânia, Goiás, 74210-010
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro
Novartis Investigative Site
São Paulo, São Paulo, 01501-000

Other trials in Brazil

India6 sites

Novartis Investigative Site
Ahmedabad, 380009
Novartis Investigative Site
Chennai, Tamil Nadu, 600 006
Novartis Investigative Site
Coimbatore, Tamil Nadu, 641 014
Novartis Investigative Site
Hyderabad, Telangana, 500 034
Novartis Investigative Site
New Delhi, 110 029
Novartis Investigative Site
Pātia, Bhudaneswar, 751 024

Other trials in India

Mexico6 sites

Novartis Investigative Site
Col. Lomas de Chapultepec, CP, 11000
Novartis Investigative Site
Mérida, Yucatán
Novartis Investigative Site
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About this study

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

Conditions: Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Being tested: Ranibizumab
Keywords: Ophthalmology, age-related macular degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, ranibizumab, Ophthalmology, Age-related macular degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, LUMINOUS, Ranibizumab
Medical subject headings: Retinal Vein Occlusion, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RanibizumabDrug
RanibizumabOther

Study groups in NCT01318941
Study group	Role	What they receive
Ranibizumab		Not described Receives: Drug: Ranibizumab; Other: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Visual Acuity (VA) and mean change in VA
Measured: 3,6, and 12 months from the baseline visit, and annually thereafter
Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
Measured: Defined time periods during study duration from FPFV until 30 days after LPLV
Mean visual acuity at quarterly intervals for the primary treated eye set
Measured: Quarterly intervals from baseline visit during study duration (5 years)

Secondary outcomes (5)

Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From the time the patient signed the informed consent until 30 days after study discontinuation
Number of ranibizumab injections administered per patient, per eye, and per person-year
Measured: annually
"National Eye Institute Visual Functioning Questionnaire-25" change from baseline
Measured: annually
Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination
Measured: Over time during study duration (5 years)
Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores
Measured: Over time during study duration (5 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2011Apr 2016

First posted21 Mar 2011 (estimated)
Study startMar 2011
Primary completionApr 2016
Study completionApr 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein OcclusionStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30,490 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01318941
Sponsor's protocol ID: CRFB002A2406
Acronym: LUMINOUS
Status last verified: May 2016
First submitted: 17 Mar 2011
Last updated: 23 May 2016
Results posted: No

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.
PubMed 33378369
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.
PubMed 32581505
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.
PubMed 32555630
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.
PubMed 32492069
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.
PubMed 25136079

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Age-Related Macular Degeneration, Neovascular Age-related Macular Degeneration

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: LUMINOUS: Study to Observe the Effectiveness and Safety of Ranibizumab Through Individualized Patient Treatment and Associated Outcomes
ClinicalTrials.gov ID: NCT01318941
Acronym / sponsor ID: LUMINOUS / CRFB002A2406
Conditions: Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, Wet Age Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Keywords: Ophthalmology, age-related macular degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, ranibizumab, Ophthalmology, Age-related macular degeneration, Diabetic Macular Edema, Retinal Vein Occlusion, LUMINOUS, Ranibizumab
Study type: Observational
Recruitment status: Completed
Enrolment: 30,490 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Mar 2011
Primary completion: Apr 2016 (actual)
Study completion: Apr 2016 (actual)
First posted: 21 Mar 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Ranibizumab	–	Drug: Ranibizumab, Other: Ranibizumab

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Outpatient ophthalmology Clinics

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ranibizumab	Drug	Ranibizumab
Ranibizumab	Other	Ranibizumab

Primary outcome

Mean Visual Acuity (VA) and mean change in VA
Time frame: 3,6, and 12 months from the baseline visit, and annually thereafter
Incidence rate, relationship and severity of treatment emergent ocular and non-ocular adverse events
Time frame: Defined time periods during study duration from FPFV until 30 days after LPLV
Mean visual acuity at quarterly intervals for the primary treated eye set
Time frame: Quarterly intervals from baseline visit during study duration (5 years)

5 secondary outcomes

Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the time the patient signed the informed consent until 30 days after study discontinuation
Number of ranibizumab injections administered per patient, per eye, and per person-year
Time frame: annually
"National Eye Institute Visual Functioning Questionnaire-25" change from baseline
Time frame: annually
Overall number of ranibizumab injections, number of visits, time interval between injections, duration of treatment, number of re-treatment, and reasons for treatment termination
Time frame: Over time during study duration (5 years)
Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores
Time frame: Over time during study duration (5 years)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
Derived from this study: PubMed 33378369Holz 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.
Derived from this study: PubMed 32581505Leys 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.
Derived from this study: PubMed 32555630Pearce 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.
Derived from this study: PubMed 32492069Mitchell 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.
Derived from this study: PubMed 25136079Schmidt-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.

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Active, not recruitingPhase 3
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

463 sites in 43 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 463 sites in Japan, United Kingdom, Spain, Australia, Russia and 38 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Visual Acuity (VA) and mean change in VA (time frame: 3,6, and 12 months from the baseline visit, and annually thereafter). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01318941, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2016.

Trial summary

Key requirements

Who may be able to join

Who cannot join

Trial locations and contacts

About this study

What participants receive

What is being measured

Timeline

Resources

More details

Publications

Study at a glance

Clinical summary

Study design

Who may qualify

Key inclusion criteria (2 listed)

Key exclusion criteria (3 listed)

Interventions

Primary outcome

Results and safety

Research links

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

A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders

Referral and contact

Questions about this trial