Observation of Treatment Patterns With Lucentis in Approved Indications

Conditions

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

Brief summary

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.

Georg Spital, Steffen Schmitz‐Valckenberg, Bettina Müller, Erika Liczenczias, Petrus Chang et al. (9 authors)

Graefe s Archive for Clinical and Experimental Ophthalmology2024-09-193 citations

10.1007/s00417-024-06579-7

Use of Imaging Modalities in Real Life: Impact on Visual Acuity Outcomes of Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration in Germany

J Wachtlin, Georg Spital, Steffen Schmitz-Valckenberg, Sandra Liakopoulos, Jessica Vögeler et al. (8 authors)

Journal of Ophthalmology2020-07-176 citations

10.1155/2020/8024258

ORCA study: real-world versus reading centre assessment of disease activity of neovascular age-related macular degeneration (nAMD)

Sandra Liakopoulos, Georg Spital, Christian Brinkmann, Tina Schick, Focke Ziemssen et al. (11 authors)

British Journal of Ophthalmology2020-02-1716 citations

10.1136/bjophthalmol-2019-315717

Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study.

Callizo J, Ziemssen F, Bertelmann T, Feltgen N, Vögeler J, Koch M, Eter N, Liakopoulos S, Schmitz-Valckenberg S, Spital G.

2019-11-0734 citations

10.2147/opth.s209253

Intravitreal Ranibizumab Therapy for Diabetic Macular Edema in Routine Practice: Two-Year Real-Life Data from a Non-interventional, Multicenter Study in Germany.

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.

2018-10-0439 citations

10.1007/s13300-018-0513-2

Demographics of patients receiving Intravitreal anti-VEGF treatment in real-world practice: healthcare research data versus randomized controlled trials.

Ziemssen F, Feltgen N, Holz FG, Guthoff R, Ringwald A, Bertelmann T, Wiedon A, Korb C, OCEAN study group.

2017-01-1951 citations

10.1186/s12886-017-0401-y

Bertelmann T, Feltgen N, Scheffler M, Hufenbach U, Wiedon A, Wilhelm H, Ziemssen F.

2016-09-2024 citations

10.1186/s12955-016-0536-1

Regionale Unterschiede in der Versorgung von Patienten mit neovaskulärer altersabhängiger Makuladegeneration in einer nicht interventionellen Beobachtungsstudie (OCEAN)

Focke Ziemssen, U. Hufenbach, A. Wiedon, Michael Scheffler, Thomas Bertelmann

Klinische Monatsblätter für Augenheilkunde2016-07-255 citations

10.1055/s-0042-100472

[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)].

Ziemssen F, Bertelmann T, Hufenbach U, Scheffler M, Liakopoulos S, Schmitz-Valckenberg S.

2016-02-0117 citations

10.1007/s00347-015-0099-2

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Change from Baseline in Visual Acuity (VA) to Month 12	Baseline, Month 12	Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.
Change from Baseline in Visual Acuity (VA) to Month 24	Baseline, Month 24	Visual Acuity is measured either with ETDRS Scores, Snellen or decimal Scale according to routine clinical practice. Measurements are transferred to LogMAR for statistical analysis. LogMAR is defined as logarithm of the minimum angle of resolution.

Countries

Germany

Outcome results