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TREATMENT OF NEOVASCULAR AGE-RELATED MACULAR DEGENERATION PATIENTS WITH VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITORS IN EVERYDAY PRACTICE: Identification of Health Care Constraints in Germany—The PONS Study

Ehlken, Christoph, MD*,†; Wilke, Thomas, PhD; Bauer-Steinhusen, Ulrike, PhD§; Agostini, Hansjürgen, T., MD*; Hasanbasic, Zoran, PhD§; Müller, Sabrina, PhD

doi: 10.1097/IAE.0000000000001681
Original Study

Purpose: The PONS study was conceived to analyze the extent of nonpersistence (NP) and nonadherence (NA) in the treatment of patients with neovascular age-related macular degeneration in everyday clinical practice in Germany. Further objectives were to identify factors that can affect NP and NA and to analyze clinical outcomes under everyday conditions.

Methods: Nonpersistence (no contact with doctor for at least 3 months) and NA (no treatment or follow-up for at least 6 weeks) as well as clinical data were analyzed up to 24 months retrospectively and 12 months prospectively in 480 patients with neovascular age-related macular degeneration in 23 treatment centers. Patients were interviewed for factors possibly affecting NP and NA.

Results: One third of patients fulfilled criteria of NA in the first 3 months and two thirds after 6 months. The NP was 18.8% after 12 months. Treatment exclusively at one center, a higher number of patients with neovascular age-related macular degeneration at the treating center, and fixed appointments were associated with a lower risk for NP. An initial gain in visual acuity after upload was not preserved after 12 months (mean change −0.5 Early Treatment Diabetic Retinopathy Study letters). Whereas visual acuity declined by 7.5 Early Treatment Diabetic Retinopathy Study letters in patients with good baseline visual acuity >20/40, visual acuity improved by 8.5 letters in patients with baseline visual acuity of ≤20/200. Only 7.5% of patients underwent an optical coherence tomography scan after 3 upload injections, and only 2.0 optical coherence tomographies were performed in the first 12 months.

Conclusion: The NP and NA were high in our study population and are likely to have contributed to a suboptimal clinical outcome compared with randomized clinical trials. Shortcomings in the management of patients with neovascular age-related macular degeneration, including restrictions in the timely and adequate follow-up (including optical coherence tomography) and retreatment, appear to be constraining factors in Germany.

The clinical management of patients with wet age-related macular degeneration in real life is complicated by health care constraints. This study was designed to analyze nonadherence and nonpersistence as well as potential contributing factors and clinical outcomes in patients treated for wet AMD in Germany.

*Department of Ophthalmology, Albert-Ludwigs-University, Freiburg im Breisgau, Germany;

Department of Ophthalmology, Faculty of Medicine, Christian-Albrechts-University, Kiel, Germany;

Institut für Pharmaökonomie und Arzneimittellogistik (IPAM), Wismar, Germany; and

§Bayer Vital GmbH, Leverkusen, Germany.

Reprint requests: Christoph Ehlken, MD, Department of Ophthalmology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Arnold-Heller-Strasse 3, 24105 Kiel, Germany; e-mail: christoph.ehlken@uksh.de

Supported by Bayer Vital GmbH, Leverkusen, Germany. Language check was provided by Alistair Reeves, Ascribe Medical Writing and Translation (Wiesbaden, Germany) and was funded by Bayer Vital GmbH.

Preliminary results of this study were presented at the annual meetings of the Deutsche Ophthalmologische Gesellschaft (DOG), September 19, 2013, Berlin, Germany, and September 26, 2014, Leipzig, Germany.

None of the authors has any conflicting interests to disclose.

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© 2018 by Ophthalmic Communications Society, Inc.