Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications

NCT04847895 | Completed

• 1 other identifier: CRFB002ADE28
• Study Type: observational
• Target: 5,500
• Locations: 3 countries
• Sites: 175

Brief Summary

This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.

Conditions

Neovascular (Wet) Age-related Macular Degeneration

Keywords

Lucentis; Ranibizumab; Neovascular (wet) age-related macular degeneration; nAMD; diabetic macular edema; retinal vein occlusions; choroidal neovascularizations

Outcome Measures

Primary Outcomes (2)

• mean change in visual acuity

  Visual acuity will be measured according to the method used by each participating physician in his/her routine practice. To be able to integrate different visual acuity assessment methods for analysis, visual acuity assessments performed using Snellen or decimal notation will be converted into an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score equivalent.

  Baseline, Up to month 24

• mean change in central retinal thickness

  As central retinal thickness data is optional, this analysis will be performed only if data allow.

  Baseline, Up to month 24

Secondary Outcomes (12)

• Number of treatments

  Up to 24 months

• Number of visits

  Up to 24 months

• Time interval between treatments

  Up to 24 months

• Time interval between visits

  Up to 24 months

• Duration of treatment period

  Up to 24 months

Study Arms (1)

Lucentis

Patients administered Lucentis by prescription

Drug: Lucentis

Interventions

Lucentis DRUG

There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.

Lucentis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients being treated with Lucentis® for any approved indication included in the local product posology. Patients will be enrolled from approximately 211 centers across Europe.

You may qualify if:

• Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC
• Written informed consent

You may not qualify if:

• As described in Lucentis® SmPC
• Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (175)

Novartis Investigative Site

Ettlingen, Baden-Wurttemberg, 76275, Germany

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Novartis Investigative Site

Ahaus, 48683, Germany

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Andernach, 56626, Germany

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Augsburg, 86150, Germany

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Augsburg, 86179, Germany

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Bad Arolsen-Meneringhausen, 34454, Germany

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Bad Liebenzell, 75378, Germany

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Bad Säckingen, 79713, Germany

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Baden-Baden, 76530, Germany

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Bautzen, 02625, Germany

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Novartis Investigative Site

Beckum, 59269, Germany

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Berlin, 10367, Germany

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Berlin, 10623, Germany

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Berlin, 10629, Germany

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Berlin, 10787, Germany

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Berlin, 12057, Germany

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Berlin, 12683, Germany

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Berlin, 13357, Germany

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Berlin, 14163, Germany

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Berlin, 14169, Germany

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Bielefeld, 33602, Germany

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Bonn, 53177, Germany

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Borna, 04552, Germany

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Braunschweig, 38100, Germany

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Breisach, 79206, Germany

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Bremen, 28219, Germany

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Bremerhaven, 27568, Germany

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Bremerhaven, 27578, Germany

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Bremervörde, 27432, Germany

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Brühl, 50321, Germany

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Buchholz, 21244, Germany

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Buxtehude, 21614, Germany

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Celle, 29221, Germany

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Cham, 93413, Germany

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Chemnitz, 09113, Germany

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Chemnitz, 09116, Germany

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Cologne, 50935, Germany

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Coswig, 01640, Germany

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Dannenberg, 29451, Germany

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Darmstadt, 64297, Germany

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Dresden, 01067, Germany

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Dresden, 01157, Germany

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Dresden, 01257, Germany

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Dresden, 01307, Germany

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Dresden, 01324, Germany

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Düsseldorf, 40212, Germany

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Düsseldorf, 40476, Germany

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Düsseldorf, 40625, Germany

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Eckental, 90542, Germany

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Ehingen, 89584, Germany

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Einbeck, 37574, Germany

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Erding, 85435, Germany

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Erkrath, 40699, Germany

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Esslingen am Neckar, 73728, Germany

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Frankenthal, 67227, Germany

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Frankfurt, 60590, Germany

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Frankfurt am Main, 60596, Germany

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Freudenstadt, 72250, Germany

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Friedberg, 86316, Germany

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Fulda, 36037, Germany

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Garching, 85748, Germany

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Glauchau, 08371, Germany

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Göttingen, 37073, Germany

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Göttingen, 37085, Germany

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Gütersloh, 33330, Germany

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Halle, 06114, Germany

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Halle, 06118, Germany

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Hamburg, 20099, Germany

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Hamburg, 21029, Germany

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Hamburg, 22159, Germany

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Hamburg, 22391, Germany

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Hamburg, 22529, Germany

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Hamburg, 22587, Germany

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Heidelberg, 69120, Germany

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Heppenheim an der Bergstrasse, 64646, Germany

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Herrsching am Ammersee, 82211, Germany

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Herzberg, 37412, Germany

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Homburg, 66421, Germany

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Hoppegarten, 15366, Germany

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Höhr-Grenzhausen, 56203, Germany

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Hösbach, 63768, Germany

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Jülich, 52428, Germany

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Kaiserslautern, 67655, Germany

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Karlsruhe, 76185, Germany

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Kempten, 87435, Germany

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Kiel, 24105, Germany

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Koblenz, 56072, Germany

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Leer, 26789, Germany

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Leipzig, 04106, Germany

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Leipzig, 04229, Germany

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Ludwigshafen, 67059, Germany

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Ludwigshafen, 67069, Germany

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Lübeck, 23538, Germany

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Mainz, 55116, Germany

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Mainz, 55124, Germany

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Mainz, 55131, Germany

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Meiben, 01662, Germany

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Minden, 32427, Germany

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Moers, 47441, Germany

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Mutterstadt, 67112, Germany

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München, 80335, Germany

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München, 80377, Germany

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München, 80637, Germany

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München, 81925, Germany

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München, 85356, Germany

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Münster, 48143, Germany

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Münster, 48145, Germany

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Neu-Ulm, 89231, Germany

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Neubrandenburg, 17033, Germany

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Neubrandenburg, 17036, Germany

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Neustadt, 67433, Germany

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Neustadt A. D. Weinstraße, 67433, Germany

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Neutraubling, 93073, Germany

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Neuwied, 56564, Germany

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Nuremberg, 90403, Germany

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Obernkirchen, 31683, Germany

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Offenburg, 77654, Germany

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Oldenburg, 26121, Germany

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Oldenburg, 26123, Germany

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Osnabrück, 49076, Germany

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Paderborn, 33098, Germany

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Paderborn, 33100, Germany

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Peine, 31224, Germany

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Pfaffenhofen, 85276, Germany

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Pirna, 01796, Germany

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Plauen, 08523, Germany

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Polch, 56751, Germany

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Prien am Chiemsee, 83209, Germany

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Quakenbrück, 49610, Germany

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Raesfeld, 46348, Germany

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Ratingen, 40885, Germany

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Regensburg, 93 047, Germany

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Rhauderfehn, 26817, Germany

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Rheine, 48429, Germany

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Rostock, 18057, Germany

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Rüsselsheim am Main, 65428, Germany

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Saarbrücken, 66113, Germany

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Saarbrücken, 66119, Germany

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Saarburg, 54439, Germany

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Saarlouis, 66740, Germany

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Salzgitter, 38226, Germany

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Schweinfurt, 97421, Germany

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Siegen, 57072, Germany

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Sindelfingen, 71063, Germany

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Speyer, 67346, Germany

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Straubing, 94315, Germany

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Torgau, 04860, Germany

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Trier, 54290, Germany

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Troisdorf, 53844, Germany

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Tübingen, 72076, Germany

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Ulm, 89073, Germany

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Waldshut-Tiengen, 79761, Germany

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Wedel, 22880, Germany

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Westerstede, 26655, Germany

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Wismar, 23966, Germany

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Worms, 67547, Germany

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Würzburg, 97080, Germany

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Bergen op Zoom, North Brabant, 4611 AN, Netherlands

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Heerhugowaard, North Holland, 1703 DC, Netherlands

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's-Hertogenbosch, 5223 GZ, Netherlands

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Novartis Investigative Site

Deventer, 7416 SE, Netherlands

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Rotterdam, 3011 BH, Netherlands

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Rotterdam, 3079 DZ, Netherlands

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Terneuzen, 4535 PA, Netherlands

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Tilburg, NL-5022GC, Netherlands

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Bern, Canton of Bern, 3011, Switzerland

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Neuchâtel, Canton of Neuchâtel, 2000, Switzerland

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Wil, Canton of St. Gallen, 9500, Switzerland

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Aarau, 5001, Switzerland

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Basel, 4051, Switzerland

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Basel, 4056, Switzerland

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Fribourg, 1708, Switzerland

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Geneva, 1204, Switzerland

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Geneva, 1205, Switzerland

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Zurich, 8091, Switzerland

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MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 19, 2021
• Study Start: June 1, 2015
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: April 19, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (8); CH (10); DE (157)