Observation of Treatment Patterns With Lucentis in Approved Indications

NCT ID: NCT02194803

Last Updated: 2017-03-01

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

5778 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-08

Study Completion Date

2016-12-31

Brief Summary

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A multicentre, open-label, non-interventional study to observe treatment patterns in patients with wet age-related macular degeneration (wAMD), with visual impairment due to diabetic macular edema (DME), due to macular edema following retinal vein occlusion (RVO) or due to chorioidal neovascularization following pathologic myopia (mCNV) with repeated intravitreal injections of Lucentis® (Ranibizumab) including optional OCT monitoring over a 24 months observational period under real life conditions.

Detailed Description

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Conditions

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Neovascular AMD, Visual Impairment Due to DME, Visual Impairment Due to Macular Oedema Secondary to Branch or Central RVO, Visual Impairment Due to CNV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* Presence of

* 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

* As described in the SmPC.
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Tübingen, , Germany

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 39294392 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32066561 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30288700 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28103831 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26201460 (View on PubMed)

Other Identifiers

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CRFB002ADE18

Identifier Type: -

Identifier Source: org_study_id

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