Observation of Treatment Patterns With Lucentis in Approved Indications
NCT ID: NCT02194803
Last Updated: 2017-03-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5778 participants
OBSERVATIONAL
2011-12-08
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort with routine OCT monitoring
No interventions assigned to this group
Cohort without routine OCT monitoring
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* neovascular (wet) age-related macular degeneration (AMD),
* visual impairment due to diabetic macular oedema (DME),
* visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) or
* visual impairment due to choroidal neovascularisation (CNV) secondary to pathologic myopia (PM)
* Patients for whom a therapy with Lucentis® is medically indicated.
* Written patients informed consent.
Exclusion Criteria
* Preceding intravitreal treatment of the study eye with anti-VEGF drugs in the last three months before enrollment
* Preceding intravitreal treatment of the study eye with steroids
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Tübingen, , Germany
Countries
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References
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Spital G, Schmitz-Valckenberg S, Muller B, Liczenczias E, Chang P, Heimes-Bussmann B, Ziemssen F, Liakopoulos S; ORCA study group. Interpretation of SD-OCT imaging data in real-life conditions versus standardized reading centre analysis in eyes with diabetic macular oedema or macular oedema secondary to retinal vein occlusion: 24-month follow-up of the ORCA study. Graefes Arch Clin Exp Ophthalmol. 2025 Jan;263(1):131-139. doi: 10.1007/s00417-024-06579-7. Epub 2024 Sep 19.
Liakopoulos S, Spital G, Brinkmann CK, Schick T, Ziemssen F, Voegeler J, Koch M, Kirchhof B, Holz FG, Pauleikhoff D, Schmitz-Valckenberg S. ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD). Br J Ophthalmol. 2020 Nov;104(11):1573-1578. doi: 10.1136/bjophthalmol-2019-315717. Epub 2020 Feb 17.
Ziemssen F, Wachtlin J, Kuehlewein L, Gamulescu MA, Bertelmann T, Feucht N, Voegeler J, Koch M, Liakopoulos S, Schmitz-Valckenberg S, Spital G; OCEAN study group. Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany. Diabetes Ther. 2018 Dec;9(6):2271-2289. doi: 10.1007/s13300-018-0513-2. Epub 2018 Oct 4.
Ziemssen F, Feltgen N, Holz FG, Guthoff R, Ringwald A, Bertelmann T, Wiedon A, Korb C; OCEAN study group. Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials. BMC Ophthalmol. 2017 Jan 19;17(1):7. doi: 10.1186/s12886-017-0401-y.
Ziemssen F, Bertelmann T, Hufenbach U, Scheffler M, Liakopoulos S, Schmitz-Valckenberg S. [Delayed treatment initiation of more than 2 weeks. Relevance for possible gain of visual acuity after anti-VEGF therapy under real life conditions (interim analysis of the prospective OCEAN study)]. Ophthalmologe. 2016 Feb;113(2):143-51. doi: 10.1007/s00347-015-0099-2. German.
Other Identifiers
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CRFB002ADE18
Identifier Type: -
Identifier Source: org_study_id
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