Klinische Entscheidungsfindung bei der Behandlung des diabetischen Makulaödems mit DEX-Implantat: ein Konsenspapier

Zusammenfassung

Hintergrund In Deutschland sind 2 intravitreal anzuwendende Kortikosteroide (Dexamethason und Fluocinolon) für die Behandlung des diabetischen Makulaödems (DMÖ) zugelassen. Der Einsatz von DEX-Implantat bei DMÖ ist in der täglichen Praxis bisher nicht im Detail definiert. Mithilfe eines Delphi-Panels und einer Runde von Retinaspezialisten sollte ein Konsens für die Anwendung von DEX-Implantat erarbeitet werden.

Material und Methoden Aus der Literatur wurden internationale und nationale Behandlungsempfehlungen identifiziert. Eine Steuerungsgruppe erarbeitete einen Katalog von 72 Aussagen zur Ätiologie und Pathogenese des DMÖ, Therapie mit dem DEX-Implantat, Einsatz bei mit VEGF-Hemmern vorbehandelten Patienten, Verwendung von DEX-Implantat in der Kombination mit anderen Therapien, Sicherheit von DMÖ-Therapien sowie Therapiebelastung des Patienten. 22 niedergelassene Ophthalmologen und 6 Ophthalmologen aus der Klinik gaben über Survey Monkey ihre Bewertung zu den Aussagen ab. Die Definition des Konsenses zu einer Aussage galt als erfüllt, wenn mehr als 75% der Befragten einer Aussage zustimmten bzw. nicht zustimmten. Über nicht konsensfähige Aussagen wurde nach erneuter Diskussion in der Konsensrunde nochmals abgestimmt. In der Folge sollte auch ein Behandlungsschema für DMÖ mit fovealer Beteiligung vorgeschlagen werden.

Ergebnisse Sofern ein Patient unter VEGF-Hemmern unzureichend anspricht (Visusgewinn < 5 ETDRS-Buchstaben oder Reduktion der zentralen Netzhautdicke ≤ 20%), sollte nach 3 – 6 Monaten auf das DEX-Implantat umgestellt werden. DEX-Implantat ist ebenfalls geeignet für Augen mit länger bestehendem DMÖ, bei denen z. B. massive Lipidexsudate vorhanden sind. DEX-Implantat eignet sich als Ersttherapie insbesondere bei Pseudophaken, Patienten, die nicht willens oder in der Lage sind, enge Injektionsintervalle unter Anti-VEGF-Therapie einzuhalten oder für Patienten mit vaskulären Vorerkrankungen. Bei festgelegten Kontrollintervallen von 4 – 8 Wochen kann die Anwendung des DEX-Implantats flexibel und individuell erfolgen. Als Entscheidungsparameter gelten hierbei neben Visus und Netzhautdicke auch der Augeninnendruck. Eine Behandlung von beiden Augen am selben Tag sollte nicht stattfinden.

Schlussfolgerungen Der hier vorgestellte Algorithmus entspricht den Ergebnissen des Delphi-Prozesses und weicht u. U. von den Empfehlungen der Fachgesellschaft ab. Die im Rahmen der Befragung und Expertenrunde erarbeiteten Konsensempfehlungen für die Therapie von DMÖ können für den Einsatz des DEX-Implantats in der täglichen Praxis dienen.

Abstract

Background Currently two intravitreally applied corticosteroids (dexamethasone and fluocinolone) are licensed in Germany for treatment of diabetic macular oedema (DME). The use of DEX implant for DME in daily clinical practice has not been defined in detail. Following a Delphi panel survey, a group of retina experts set out to come up with a consensus for use of the DEX implant in DME.

Material and Methods International and national treatment recommendations were identified from the literature. A steering group generated a catalogue of 72 statements on the aetiology and pathogenesis of DME, therapy with DEX implant, use of DEX implant in patients previously treated with VEGF-inhibitors, use of DEX implant in combination therapy, safety of DME therapies as well as patientsʼ burden of treatment. Twenty-two ophthalmologists from private practice and 6 hospital ophthalmologists participated in the Delphi panel via Survey Monkey. Consensus was reached if at least 75% of participants agreed or disagreed with a statement. Statements for which consensus was not reached were discussed once more during the expert consensus meeting and a vote was taken. Based on these results a treatment algorithm for foveal DME was proposed.

Results If a patient does not show sufficient response after 3 – 6 months of anti-VEGF treatment (visual acuity gain of < 5 ETDRS letters or reduction of central retinal thickness ≤ 20%), a switch to DEX implant should take place. DEX implant is also suitable in eyes with longer presentation of DME, showing e.g. massive lipid exudates. DEX implant is suitable as first-line therapy especially in pseudophakic patients, patients unwilling or able to comply with tight anti-VEGF injection intervals or patients with known vascular diseases. With fixed control visits every 4 – 8 weeks, use of DEX implant is flexible and individual. Decision parameters for repeated use should be visual acuity, retinal thickness and intraocular pressure. Treatment of both eyes on the same day should not take place.

Conclusion The algorithm presented reflects survey as well as expert discussion results and may differ from recommendations issued by the German professional society. The consensus recommendations for the treatment of DME generated during the survey and meeting of retina experts are intended to guide use of DEX implant in daily practice.

Schlüsselwörter

Delphi-Konsens - diabetisches Makulaödem - klinische Praxis - DEX Implantat - Behandlungsalgorithmus

Key words

Delphi consensus - diabetic macular edema - clinical practice - DEX implant - treatment algorithm

Publication History

Received: 04 May 2019

Accepted: 17 September 2019

Article published online:
26 November 2019

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