Verzögerung des Behandlungsbeginns um mehr als 2 Wochen

Ziemssen, Focke; Bertelmann, Thomas; Hufenbach, U.; Scheffler, Michael; Liakopoulos, Sandra; Schmitz-Valckenberg, Steffen

doi:10.1007/s00347-015-0099-2

Cited by 23 publications

(11 citation statements)

References 26 publications

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“…OCEAN participants with DME were recruited from 250 centers, including 49 general ophthalmology practices, where monitoring and treatment were documented, but patients were referred to a retina specialist for the injections. Such referrals have been shown to delay treatment start [ 16 ] and may also affect further treatment [ 25 , 26 ].…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2018

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IntroductionThe prospective, non-interventional OCEAN study examined the use of intravitreal ranibizumab injections for the treatment of diabetic macular oedema (DME) in a real-world setting in Germany.MethodsAdults with DME receiving ≥ 1 ranibizumab (0.5 mg) injections were recruited by 250 ophthalmologists. Best-corrected visual acuity (VA) testing, imaging and treatments were performed according to the investigators’ routine practice and documented over 24 months.ResultsThe full analysis set included 1226 participants. Mean baseline VA was 60.6 [95% CI: 59.7; 61.5] Early Treatment Diabetic Retinopathy Study letters. VA improved by ≥ 15 letters in 21.5% and 23.5% of the participants at 12 months and 24 months, respectively. They received a mean number of 4.42 [95% CI: 4.30; 4.54] injections in the first year and 5.52 [95% CI: 5.32; 5.73] injections over 24 months, which was markedly lower than in clinical trials. Only 33.4% of the participants received an upload with four initial monthly injections as recommended by the German ophthalmologic societies. Time-to-event analyses that account for missing data inherent to a non-interventional study design demonstrated that participants receiving ≥ 7 injections in the first year had a faster response, but the duration of the response was shorter compared to the subgroups receiving 1–3 and 4–6 injections. Serious adverse events were reported for 143/1250 (11.4%) participants in the safety population.ConclusionUnder-treatment is a major problem of DME anti- vascular endothelial growth factor therapy under real life conditions. Despite fewer injections given compared to randomised controlled trials with a consequently reduced overall mean visual gain, a profound functional improvement (≥ 15 letters) was achieved over 2 years in 23.5% of eyes with DME.Trial Registration NumberNCT02194803, ClinicalTrials.gov.FundingNovartis Pharma GmbH, Nuremberg, Germany.Electronic supplementary materialThe online version of this article (10.1007/s13300-018-0513-2) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 99%

“…Values for best-corrected VA were converted to logarithm of minimum angle of resolution (LogMAR) values and Early Treatment Diabetic Retinopathy Study (ETDRS) letters [ 16 ].…”

Section: Methodsmentioning

confidence: 99%

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

et al. 2018

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“…Unlike in other countries, access to ranibizumab or appropriately scheduled appointments for treatment in Germany is not problematic and thus seems a rather unlikely explanation. It has been shown by the AURA 13 14 (Study to Assess the Effectiveness of Existing Anti vascular Endothelial Growth Factor in Patients witn wet Age-related Macular Degeneration) and WAVE 12 (Lucentis in Wet AMD: Evaluation of Visual Acuity and Quality of Life) studies, as well as in another module of the OCEAN study, 20 that delayed or reduced ranibizumab injections lead to a decreased improvement of visual acuity. The importance of correct and timely treatment is emphasised by the fact that vision loss was documented at the subsequent visit for more than one-third of the scans with potential undertreatment in the present study.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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Background/aimsThe prospective, non-interventional ORCA module of the OCEAN study (Observation of Treatment Patterns with Lucentis in Approved Indications) evaluated the qualiy of spectral domain-optical coherence tomography (SD-OCT) image interpretation and treatment decisions by clinicians in Germany and the impact on visual outcomes over 24 months in patients with neovascular age-related macular degeneration (nAMD).Methods2286 SD-OCT scans of 205 eyes were independently evaluated by clinicians and reading centres (RCs) regarding signs of choroidal neovascularisation (CNV) activity, including presence of intraretinal fluid, subretinal fluid, and/or increase in pigment epithelial detachments. Agreement between clinicians and RCs was calculated. Treatment decisions by clinicians and the impact on treatment outcomes were evaluated.ResultsCNV activity was detected by RCs on 1578 scans (69.0%) and by clinicians on 1392 scans (60.9%), with agreement in 74.9% of cases. Of the 1578 scans with RC detected CNV activity, anti-vascular endothelial growth factor injections were performed by clinicians in only 35.5% (560/1578). In 19.7% of cases (311/1578), lack of treatment was justified by patients request, termination criteria or chronic cystoid spaces without other signs for CNV activity. In 44.8% of cases (707/1578) with RC detected CNV activity, clinicians claimed no treatment was necessary despite having correctly detected CNV activity in about 2/3 of these cases. In 34% of cases with presumed undertreatment, visual acuity declined in the following visit.ConclusionAlthough broad agreement on CNV activity parameters was observed between clinicians and RCs, correct identification of CNV activity did not always lead to the initiation of (re-)treatment. To preserve vision over time, correct interpretation of SD-OCT scans and careful retreatment decisions are required.Trial registration numberNCT02194803.

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“…IVOM. Zudem sollte ein zeitnaher Behandlungsbeginn innerhalb von 14 Tagen gewährleistet werden [12]. Hier spielen Terminvergaben zwischen den beteiligten Ärzten und Absprachen von Patienten mit Angehörigen oder Fahrdienstleistern eine entscheidende Rolle.…”

Section: Zusammenfassungunclassified

“…Ziemssen et al postulieren, dass ein Zeitintervall zwischen SD-OCT-Diagnose und notwendiger Therapie von mehr als 14 Tagen zu schlechteren funktionellen und anatomischen Ergebnissen bei Langzeittherapie führt [12]. Wir konnten innerhalb des Portalsystems im Mittel 7,8 Tage nach Diagnose die Wiederbehandlung beginnen.…”

Section: D) Analyse Der Therapieabbrücheunclassified

Analyse des Versorgungsmodells „Portal“ – Untersuchung der Ergebnisqualität der IVOM-Therapie im Hinblick auf Latenzzeiten bei exsudativer AMD

Rothaus

Farecki

Mussinghoff

et al. 2019

Klin Monbl Augenheilkd

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Zusammenfassung Hintergrund Die intravitreale operative Medikamenteneingabe (IVOM) stellte gegenwärtig bei vielen Makulopathien eine logistische Herausforderung für Patient und Arzt dar. Während die Patienten die Fahrten zu den Arztbesuchen organisieren müssen, haben die medizinischen Einrichtungen ausreichend kurzfristige Ressourcen vorzuhalten, um eine zeitnahe und termingerechte Behandlung zu gewährleisten. Ziel dieser Studie ist die Evaluation der kooperativen IVOM-Therapie bei Patienten mit einer exsudativen AMD hinsichtlich der folgenden 4 Qualitätsindikatoren: a) der Latenzzeiten innerhalb des Behandlungs- und Kontrollzyklus, b) die Behandlungsfrequenzen, c) die Adhärenz und d) das medizinische Ergebnis. Patienten und Methode In Zusammenarbeit vieler Augenärzte werden seit über 7 Jahren AMD-Patienten innerhalb eines Portalsystems kooperativ behandelt. Dabei werden zwischen der konventionell behandelnden Praxis und dem operativen Zentrum die für die Behandlung wesentlichen Daten ausgetauscht. Insgesamt wurden von 1850 Patienten insgesamt 2283 wegen AMD zu behandelnde Augen dokumentiert. Diese elektronische Dokumentation wurde hinsichtlich der o. g. Qualitätsindikatoren retrospektiv ausgewertet. Ergebnisse Die Auswertung ergab eine durchschnittliche Latenzzeit zwischen der Kontrolle beim konservativen Augenarzt und einem erneuten Start einer IVOM-Serie von 8,1 Werktagen. Innerhalb der ersten beiden Behandlungsjahre wurden durchschnittlich 10,5 Injektionen und 8,2 Kontrolltermine pro Fall erreicht. Dabei waren nach den 2 Jahren noch 72,9% der Fälle in Behandlung bzw. Beobachtung und es konnte eine Stabilisierung des Visusgewinns von durchschnittlich 0,05 logMAR erreicht werden. Schlussfolgerung Gerade bei der exsudativen AMD ist eine konsequente Therapie über Jahre von essenzieller Bedeutung für ein funktionelle Stabilität und Verbesserung der Sehleistung. Die Analyse des Versorgungsmodells zeigt, dass eine kooperative Organisation der IVOM-Therapie und Verlaufsdiagnostik im PRN-Schema zu einer konsequenten Behandlung und den notwendigen Kontrolluntersuchungen der Patienten über einen langen Zeitraum führen kann.

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Verzögerung des Behandlungsbeginns um mehr als 2 Wochen

Abstract: Every patient should be treated within 14 days, following recent recommendations of the ophthalmological societies. Liability issues have to be considered as the statistical evaluation of real life data showed unambiguous results.

Cited by 23 publications

References 26 publications

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

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

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

Analyse des Versorgungsmodells „Portal“ – Untersuchung der Ergebnisqualität der IVOM-Therapie im Hinblick auf Latenzzeiten bei exsudativer AMD

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