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This study will describe the long-term safety and effectiveness, treatment patterns,and patient reported quality of life associated with ranibizumab treatment in routine clinical practice for all approved indication included in the local product label.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ranibizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ranibizumab | Drug |
| ||
| Ranibizumab |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Visual Acuity (VA) and mean change in VA | 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 | 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 | Quarterly intervals from baseline visit during study duration (5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From the time the patient signed the informed consent until 30 days after study discontinuation | |
| Number of ranibizumab injections administered per patient, per eye, and per person-year |
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Inclusion Criteria:
Exclusion Criteria:
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Outpatient ophthalmology Clinics
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Buenos Aires | Argentina | Argentina | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33378369 | Derived | 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. | |
| 32581505 |
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|
| annually |
| "National Eye Institute Visual Functioning Questionnaire-25" change from baseline | 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 | Over time during study duration (5 years) |
| Change from baseline in National Eye Institute Visual Function Questionnaire 25 composite and sub-scale scores | Over time during study duration (5 years) |
| Concepción del Uruguay |
| Argentina |
| Argentina |
| Novartis Investigative Site | Córdoba | Argentina | CP 5000 | Argentina |
| Novartis Investigative Site | Guaymallén, Mendoza | Argentina | Argentina |
| Novartis Investigative Site | Rosario | Argentina | Argentina |
| Novartis Investigative Site | San Martin, Buenos Aires | Argentina | Argentina |
| Novartis Investigative Site | Santa Fe | Argentina | Argentina |
| Novartis Investigative Site | Lanus | Buenos Aires | B1824ABE | Argentina |
| Novartis Investigative Site | Mar del Plata | Buenos Aires | Argentina |
| Novartis Investigative Site | Rosario | Santa Fe Province | Argentina |
| Novartis Investigative Site | Buenos Aires | 1121 | Argentina |
| Novartis Investigative Site | Buenos Aires | Argentina | Argentina |
| Novartis Investigative Site | Buenos Aires | CP1425 | Argentina |
| Novartis Investigative Site | Caballito | C1437AVJ | Argentina |
| Novartis Investigative Site | Ciudad de Buenos Aires, | Argentina | Argentina |
| Novartis Investigative Site | La Plata | Argentina |
| Novartis Investigative Site | Santa Fe | Argentina | Argentina |
| Novartis Investigative Site | Chatswood | New South Wales | 2067 | Australia |
| Novartis Investigative Site | Forster | New South Wales | 2428 | Australia |
| Novartis Investigative Site | Kogarah | New South Wales | 2217 | Australia |
| Novartis Investigative Site | Liverpool | New South Wales | 2170 | Australia |
| Novartis Investigative Site | North Ryde | New South Wales | 2109 | Australia |
| Novartis Investigative Site | Parramatta | New South Wales | 2150 | Australia |
| Novartis Investigative Site | Strathfield | New South Wales | 2135 | Australia |
| Novartis Investigative Site | Sydney | New South Wales | 2000 | Australia |
| Novartis Investigative Site | Sydney | New South Wales | Australia | Australia |
| Novartis Investigative Site | Westmead | New South Wales | 2145 | Australia |
| Novartis Investigative Site | Brisbane | Queensland | 4000 | Australia |
| Novartis Investigative Site | South Brisbane | Queensland | 4101 | Australia |
| Novartis Investigative Site | Southport | Queensland | 4125 | Australia |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | North Adelaide | South Australia | 5006 | Australia |
| Novartis Investigative Site | Hobart | Tasmania | 7000 | Australia |
| Novartis Investigative Site | South Launceston | Tasmania | 7249 | Australia |
| Novartis Investigative Site | East Melbourne | Victoria | 3002 | Australia |
| Novartis Investigative Site | Geelong | Victoria | 3220 | Australia |
| Novartis Investigative Site | Glen Waverley | Victoria | VIC 3150 | Australia |
| Novartis Investigative Site | Oakleigh | Victoria | 3166 | Australia |
| Novartis Investigative Site | Linz | A-4020 | Austria |
| Novartis Investigative Site | Vienna | A 1040 | Austria |
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| Novartis Investigative Site | Bonheiden | 2820 | Belgium |
| Novartis Investigative Site | Brussels | 1070 | Belgium |
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| Novartis Investigative Site | Zottegem | 9620 | Belgium |
| Novartis Investigative Site | Goiânia | Goiás | 74210-010 | Brazil |
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| Novartis Investigative Site | Halifax | Nova Scotia | B3H 2A5 | Canada |
| Novartis Investigative Site | Brampton | Ontario | L6Y 0P6 | Canada |
| Novartis Investigative Site | Downsview | Ontario | M5N 2V6 | Canada |
| Novartis Investigative Site | East Brockville | Ontario | K6V 0V6 | Canada |
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| Novartis Investigative Site | Boisbriand | Quebec | J7H 1S6 | Canada |
| Novartis Investigative Site | Barrie | ON L4M 4S | Canada |
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| Novartis Investigative Site | Olomouc | 775 20 | Czechia |
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| Novartis Investigative Site | Poitiers | France | 86000 | France |
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| Novartis Investigative Site | Dijon | 21034 | France |
| Novartis Investigative Site | Lyon | 69317 | France |
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| Novartis Investigative Site | Augsburg | 86156 | Germany |
| Novartis Investigative Site | Berlin | 10367 | Germany |
| Novartis Investigative Site | Berlin | 10707 | Germany |
| Novartis Investigative Site | Bonn | D-53105 | Germany |
| Novartis Investigative Site | Cologne | 50924 | Germany |
| Novartis Investigative Site | Dannenberg | 29451 | Germany |
| Novartis Investigative Site | Hamburg | 22587 | Germany |
| Novartis Investigative Site | Ingolstadt | 85049 | Germany |
| Novartis Investigative Site | Lüdenscheid | 58515 | Germany |
| Novartis Investigative Site | Münster | 48145 | Germany |
| Novartis Investigative Site | Münster | 48149 | Germany |
| Novartis Investigative Site | Neu-Ulm | 89231 | Germany |
| Novartis Investigative Site | Osnabrück | 49076 | Germany |
| Novartis Investigative Site | Regensburg | 93 047 | Germany |
| Novartis Investigative Site | Rothenburg | 91541 | Germany |
| Novartis Investigative Site | Schriesheim | 69198 | Germany |
| Novartis Investigative Site | Tönisvorst | 47918 | Germany |
| Novartis Investigative Site | Tübingen | 72076 | Germany |
| Novartis Investigative Site | Alexandroupoli | Greece | 68100 | Greece |
| Novartis Investigative Site | Athens | Greece | 11525 | Greece |
| Novartis Investigative Site | Athens | Greece | 176 73 | Greece |
| Novartis Investigative Site | Athens | GR | 106 72 | Greece |
| Novartis Investigative Site | Heraklion - Crete | GR | 711 10 | Greece |
| Novartis Investigative Site | Larissa | GR | 411 10 | Greece |
| Novartis Investigative Site | Patra - RIO | GR | 265 04 | Greece |
| Novartis Investigative Site | Rethymno | GR | 741 00 | Greece |
| Novartis Investigative Site | Thessaloniki | GR | 546 29 | Greece |
| Novartis Investigative Site | Athens | 10436 | Greece |
| Novartis Investigative Site | Lamia, Phthiotis | 35100 | Greece |
| Novartis Investigative Site | Guatemala City | Departamento de Guatemala | 01010 | Guatemala |
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| Novartis Investigative Site | Budapest | 1133 | Hungary |
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| Novartis Investigative Site | Patia | Bhudaneswar | 751 024 | India |
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| Novartis Investigative Site | Ahmedabad | 380009 | India |
| Novartis Investigative Site | New Delhi | 110 029 | India |
| Novartis Investigative Site | Dublin | 18 | Ireland |
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| Novartis Investigative Site | Waterford | Ireland |
| Novartis Investigative Site | Haifa | 3339419 | Israel |
| Novartis Investigative Site | Petah Tikva | 49100 | Israel |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |
| Novartis Investigative Site | Acquaviva delle Fonti | BA | 70021 | Italy |
| Novartis Investigative Site | Cagliari | CA | 09124 | Italy |
| Novartis Investigative Site | Genova | GE | 16132 | Italy |
| Novartis Investigative Site | Alessandria | Italy |
| Novartis Investigative Site | Belluno | 32100 | Italy |
| Novartis Investigative Site | Brescia | 25123 | Italy |
| Novartis Investigative Site | Pisa | 56124 | Italy |
| Novartis Investigative Site | Reggio Calabria | 89100 | Italy |
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| Novartis Investigative Site | Nagakute | Aichi-ken | 480-1195 | Japan |
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| Novartis Investigative Site | Aomori | Aomori | 030-8553 | Japan |
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| Novartis Investigative Site | Coimbra | Portugal | 3030-163 | Portugal |
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| Novartis Investigative Site | Cheboksary | 428028 | Russia |
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| Novartis Investigative Site | Moscow | 119021 | Russia |
| Novartis Investigative Site | Novosibirsk | 630096 | Russia |
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| Novartis Investigative Site | Saint Petersburg | Russia | Russia |
| Novartis Investigative Site | Samara | 443079 | Russia |
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| Novartis Investigative Site | Surgut | 121359 | Russia |
| Novartis Investigative Site | Tambov | 392000 | Russia |
| Novartis Investigative Site | Tyumen | 625048 | Russia |
| Novartis Investigative Site | Ufa | 450077 | Russia |
| Novartis Investigative Site | Yakutsk | 677000 | Russia |
| Novartis Investigative Site | Riyadh | 11426 | Saudi Arabia |
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| Novartis Investigative Site | Singapore | Singapore | 119074 | Singapore |
| Novartis Investigative Site | Singapore | 168751 | Singapore |
| Novartis Investigative Site | Singapore | 248649 | Singapore |
| Novartis Investigative Site | Banksa Bystrica | Slovak Republic | 974 17 | Slovakia |
| Novartis Investigative Site | Trebišov | Slovak Republic | 075 01 | Slovakia |
| Novartis Investigative Site | Bratislava | Slovakia | 833 01 | Slovakia |
| Novartis Investigative Site | Nové Zámky | Slovakia | 940 34 | Slovakia |
| Novartis Investigative Site | Zvolen | Slovakia | 960 01 | Slovakia |
| Novartis Investigative Site | Žilina | Slovakia | 01207 | Slovakia |
| Novartis Investigative Site | Bratislava | 813 69 | Slovakia |
| Novartis Investigative Site | Bratislava | 851 07 | Slovakia |
| Novartis Investigative Site | Ljubljana | 1000 | Slovakia |
| Novartis Investigative Site | Poprad | 058 01 | Slovakia |
| Novartis Investigative Site | Ružomberok | 034 01 | Slovakia |
| Novartis Investigative Site | Trenčín | SK-91171 | Slovakia |
| Novartis Investigative Site | Novo Mesto | Slovenia | Slovenia |
| Novartis Investigative Site | Celje | 3000 | Slovenia |
| Novartis Investigative Site | Ljubljana | 1000 | Slovenia |
| Novartis Investigative Site | Maribor | 2000 | Slovenia |
| Novartis Investigative Site | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 443-721 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 05505 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 110 744 | South Korea |
| Novartis Investigative Site | Busan | 612-896 | South Korea |
| Novartis Investigative Site | Daegu | 705-703 | South Korea |
| Novartis Investigative Site | Pusan | 602-739 | South Korea |
| Novartis Investigative Site | Seoul | 120-752 | South Korea |
| Novartis Investigative Site | Seoul | 130-872 | South Korea |
| Novartis Investigative Site | Seoul | 137-701 | South Korea |
| Novartis Investigative Site | Seoul | 150-950 | South Korea |
| Novartis Investigative Site | Seoul | South Korea |
| Novartis Investigative Site | Taegu | 700 - 721 | South Korea |
| Novartis Investigative Site | Málaga | Andalusia | 29010 | Spain |
| Novartis Investigative Site | León | Castille and León | 24071 | Spain |
| Novartis Investigative Site | Salamanca | Castille and León | 32007 | Spain |
| Novartis Investigative Site | Valladolid | Castille and León | 47011 | Spain |
| Novartis Investigative Site | Barcelona | Catalonia | 08025 | Spain |
| Novartis Investigative Site | Sant Cugat del Vallès | Catalonia | 08190 | Spain |
| Novartis Investigative Site | Tarragona | Catalonia | 43005 | Spain |
| Novartis Investigative Site | Lugo | Galicia | 27003 | Spain |
| Novartis Investigative Site | Logroño | Hospital La Rioja Provincia | 26001 | Spain |
| Novartis Investigative Site | Murcia | Murcia | 30003 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46015 | Spain |
| Novartis Investigative Site | Valencia | Valencia | 46026 | Spain |
| Novartis Investigative Site | Zaragoza | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Barcelona | 08025 | Spain |
| Novartis Investigative Site | Burgos | 09006 | Spain |
| Novartis Investigative Site | Granollers | 08402 | Spain |
| Novartis Investigative Site | Madrid | 28008 | Spain |
| Novartis Investigative Site | Madrid | 28010 | Spain |
| Novartis Investigative Site | Madrid | 28040 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Madrid | 28805 | Spain |
| Novartis Investigative Site | Zaragoza | 50009 | Spain |
| Novartis Investigative Site | Ankara | Turkey | 06500 | Turkey (Türkiye) |
| Novartis Investigative Site | Altindag / Ankara | 06590 | Turkey (Türkiye) |
| Novartis Investigative Site | Ankara | 06100 | Turkey (Türkiye) |
| Novartis Investigative Site | Mecidiyekoy/Istanbul | 34394 | Turkey (Türkiye) |
| Novartis Investigative Site | Dnipropetrovsk | 49027 | Ukraine |
| Novartis Investigative Site | Kyiv | 03065 | Ukraine |
| Novartis Investigative Site | Luhansk | 91055 | Ukraine |
| Novartis Investigative Site | Odesa | Ukraine |
| Novartis Investigative Site | Truro | Cornwall | TR1 3LJ | United Kingdom |
| Novartis Investigative Site | Durham | County Durham | DH1 5TW | United Kingdom |
| Novartis Investigative Site | Torquay | Devon, | TQ2 7AA | United Kingdom |
| Novartis Investigative Site | Bolton | England | BL4 0JR | United Kingdom |
| Novartis Investigative Site | Solihull | England | B91 2JL | United Kingdom |
| Novartis Investigative Site | Southampton | England | SO16 6YD | United Kingdom |
| Novartis Investigative Site | Wakefield | England | WF1 3JS | United Kingdom |
| Novartis Investigative Site | Belfast | Essex | BT12 6BA | United Kingdom |
| Novartis Investigative Site | Romford | Essex | RM7 0AG | United Kingdom |
| Novartis Investigative Site | Cheltenham | Gloucestershire | GL53 7AN | United Kingdom |
| Novartis Investigative Site | Blackburn | Lancashire | BB2 3HH | United Kingdom |
| Novartis Investigative Site | Hull | Lancashire | HU3 2JZ | United Kingdom |
| Novartis Investigative Site | Leicester | Lancashire | LE1 5WW | United Kingdom |
| Novartis Investigative Site | Coventry | London | CV2 2DX | United Kingdom |
| Novartis Investigative Site | Derby | London | DE22 3NE | United Kingdom |
| Novartis Investigative Site | Leytonstone | London | E11 1NR | United Kingdom |
| Novartis Investigative Site | Oxford | Oxfordshire | OX3 9DU | United Kingdom |
| Novartis Investigative Site | Sheffield | South Yorkshire | S10 2JF | United Kingdom |
| Novartis Investigative Site | Stoke-on-Trent | Staffordshire | ST4 7LN | United Kingdom |
| Novartis Investigative Site | Frimley | Surrey | GU16 7UJ | United Kingdom |
| Novartis Investigative Site | Guildford | Surrey | GU2 7XX | United Kingdom |
| Novartis Investigative Site | Worcester | UK | WR5 1DD | United Kingdom |
| Novartis Investigative Site | London | United Kingdom | EC1V 2PD | United Kingdom |
| Novartis Investigative Site | Bradford | West Yorkshire | BD9 6RJ | United Kingdom |
| Novartis Investigative Site | Bedford | MK429DJ | United Kingdom |
| Novartis Investigative Site | Birmingham | B18 7QU | United Kingdom |
| Novartis Investigative Site | Bristol | BS1 2LX | United Kingdom |
| Novartis Investigative Site | Cardiff | CF14 4XN | United Kingdom |
| Novartis Investigative Site | Cheshire | CW1 4QJ | United Kingdom |
| Novartis Investigative Site | Colchester | CO3 3NB | United Kingdom |
| Novartis Investigative Site | Inverness | IV2 3UJ | United Kingdom |
| Novartis Investigative Site | Kent | CT1 3NG | United Kingdom |
| Novartis Investigative Site | Leeds | LS9 7TF | United Kingdom |
| Novartis Investigative Site | Liverpool | L9 7AL | United Kingdom |
| Novartis Investigative Site | London | NW1 5QH | United Kingdom |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Novartis Investigative Site | London | SE5 9RS | United Kingdom |
| Novartis Investigative Site | Maidstone | ME16 9QQ | United Kingdom |
| Novartis Investigative Site | Manchester | M13 9WL | United Kingdom |
| Novartis Investigative Site | Merseyside | CH49 5PE | United Kingdom |
| Novartis Investigative Site | Merseyside | L7 8PX | United Kingdom |
| Novartis Investigative Site | Middlesbrough | TS4 3BW | United Kingdom |
| Novartis Investigative Site | Newport | P030 5TG | United Kingdom |
| Novartis Investigative Site | Portsmouth | PO6 3LY | United Kingdom |
| Novartis Investigative Site | Southend | SS0 0RY | United Kingdom |
| Novartis Investigative Site | Sunderland | SR2 9HP | United Kingdom |
| Novartis Investigative Site | Uxbridge | UB8 3NN | United Kingdom |
| Novartis Investigative Site | Wolverhampton | WV10 0QP | United Kingdom |
| Novartis Investigative Site | York | YO31 8HE | United Kingdom |
| Novartis Investigative Site | Porlamar Local 02 | Isla Margarita | Venezuela |
| Novartis Investigative Site | Caracas | Venezuela |
| Novartis Investigative Site | Caracas, Piso 6, Ofic. 607 | Venezuela |
| Novartis Investigative Site | Santa Paula | Venezuela |
| Novartis Investigative Site | Torre Venezuela, Piso 1 | Venezuela |
| 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. |
| 32555630 | Derived | 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. |
| 32492069 | Derived | 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. |
| 25136079 | Derived | 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. |
| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012162 | Retinal Degeneration |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069579 | Ranibizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
Not provided
Not provided