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Long-term follow-up of antivascular endothelial growth factor treatment for diabetic macular oedema: a four-year real-world study
Dalarna University, School of Education, Health and Social Studies, Caring Science/Nursing. Uppsala University Hospital, Uppsala University.ORCID iD: 0000-0001-7721-8794
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2020 (English)In: Acta Ophthalmologica, ISSN 1755-375X, E-ISSN 1755-3768, Vol. 98, p. 360-367Article in journal (Refereed) Published
Abstract [en]

Purpose

To evaluate visual acuity (VA) and central retinal thickness (CRT) on optical coherence tomography during a 4‐year period in patients treated for sight‐threatening diabetic macular oedema (DMO) at two Swedish county hospitals. Additionally, to compare health‐related quality of life and subjective visual functioning before and after 4 years of treatment.

Methods

Fifty‐eight patients with DMO were evaluated after 4 years of antivascular endothelial growth factor (VEGF) treatment. VA, CRT and clinical data were retrospectively reviewed. Health‐related quality of life and subjective visual functioning were evaluated with Short Form Health Survey (SF‐36) and National Eye Institute Vision Functioning Questionnaire 25 (VFQ‐25). Comparisons between independent groups were performed using Pearson's χ2 test, Fisher's exact test or Mann–Whitney U test. Spearman's ρ was used for correlation analyses. Wilcoxon signed‐rank test was used for comparison between dependent groups. Logistic regression analysis was applied for analysis of VA and CRT over 4 years.

Results

Follow‐up data were obtained from 37 of 58 (63.8%) patients. Baseline characteristics were similar, regardless of follow‐up. VA improvement at 1 year (mean + 4.4, SD 7.5; ETDRS letter score) was maintained over 3 years, then declined. CRT was reduced throughout the study. In the first treatment year, eyes received 5.1 (1.4) anti‐VEGF injections, followed by approximately two injections yearly. Additional treatment included laser and dexamethasone implants. SF‐36 showed no change at 4 years, compared with baseline. VFQ‐25 demonstrated improvement in near vision activities (p = 0.036).

Conclusion

Significant long‐term improvement in visual function was present in patients with anti‐VEGF‐treated DMO.

Place, publisher, year, edition, pages
2020. Vol. 98, p. 360-367
Keywords [en]
anti-VEGF treatment, diabetic macular oedema, long-term follow-up, longitudinal study, real-world study, visual acuity
National Category
Health Sciences
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
URN: urn:nbn:se:du-31172DOI: 10.1111/aos.14290ISI: 000492664100001Scopus ID: 2-s2.0-85074598945OAI: oai:DiVA.org:du-31172DiVA, id: diva2:1375936
Available from: 2019-12-06 Created: 2019-12-06 Last updated: 2021-11-12Bibliographically approved
In thesis
1. Patient-reported and medical outcomes in patients treated for diabetic macular edema: A real-world longitudinal study
Open this publication in new window or tab >>Patient-reported and medical outcomes in patients treated for diabetic macular edema: A real-world longitudinal study
2020 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Background Diabetes mellitus can lead to complications, when the complication affects the eyes it is called retinopathy. This can affect the macula and lead to severe loss of vision, diabetic macular edema (DME). This condition has traditionally been treated with laser. However, in 2011, anti-vascular endothelial growth factor (anti-VEGF) injections in the eye were approved as a treatment for diabetic macular edema, and started to be used in eye clinics.

Aim The overall aim of this thesis was to describe patient-reported outcomes and medical outcomes (PRO) in people treated for diabetic macular edema in a real-world setting in a long-time follow-up study in Sweden.

Methods Participants were enrolled at two eye clinics at two county hospitals in Sweden between 2012 and 2014. Patient-reported outcomes were measured using a vision-specific questionnaire, the 25-question National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and a generic questionnaire, the Short Form-36 Health Survey (SF-36). Completed questionnaires, medical data such as visual acuity (EDRS), macula swelling (OCT) and social background characteristics were collected before treatment start, at one-year and four-year follow up points. The data was analyzed, descriptive statistics developed and comparative analyses were performed. Interviews were performed before treatment start and were analyzed using qualitative content analysis.

Results A total of 59 participants were included at baseline. The mean age was 69 years, with an equal gender distribution. At baseline, the participants scored a low general health with the vision-specific questionnaire. In total, 21 participants were interviewed, and a theme emerged of ‘being at a crossroads and a crucial phase in life with an uncertain outcome’. The participants expressed thoughts and concerns at different levels, including practical concerns about the treatment procedure and more existential thoughts about hope for improved visual acuity or fear of deterioration. The results at the one-year follow up showed that 30 patients had improved visual acuity and reported an improvement in several subscales in the NEI VFQ-25. The remaining 27 participants had no improvement in visual acuity or in the vision specific questionnaire. The four-year follow-up involved 37 people, and the result showed significant improvement in subjective near-vision activities and improved distance visual acuity.

Conclusion: Before treatment, the participants reported low general health and expressed concerns about the injection treatment and their vision. One year after treatment started, the results showed significant improvement in several NEI VFQ-25 subscales, decreased macula swelling and improved visual acuity. These positive results remained at the four-year follow-up point.

Place, publisher, year, edition, pages
Uppsala: Acta Universitatis Upsaliensis, 2020. p. 68
Keywords
Diabetes mellitus, Patient-reported outcomes, Retinopathy, Macular edema, Anti-VEGF treatment
National Category
Endocrinology and Diabetes
Research subject
Research Profiles 2009-2020, Health and Welfare
Identifiers
urn:nbn:se:du-32652 (URN)978-91-513-0896-8 (ISBN)
Public defence
2020-04-28, Aula Gunnesalen, Ingång 10, Psykiatrins hus. Akademiska sjukhuset Uppsala., 13:00 (Swedish)
Opponent
Supervisors
Available from: 2020-05-11 Created: 2020-05-11 Last updated: 2021-11-12Bibliographically approved

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Granström, ThereseLeksell, Janeth

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