Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study

Catharina Busch; Samantha Fraser-Bell; Dinah Zur; Patricio J. Rodríguez-Valdés; Zafer Cebeci; Marco Lupidi; Adrian T. Fung; Pierre-Henry Gabrielle; Ermete Giancipoli; Voraporn Chaikitmongkol; Mali Okada; Inês Laíns; Ana Rita Santos; Paradee Kunavisarut; Anna Sala-Puigdollers; Jay Chhablani; Malgorzata Ozimek; Assaf Hilely; Jan Darius Unterlauft; Anat Loewenstein; Matias Iglicki; Matus Rehak; International Retina Group

doi:10.1007/s00592-019-01310-z

Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study

Catharina Busch, Samantha Fraser-Bell, Dinah Zur, Patricio J. Rodríguez-Valdés, Zafer Cebeci, Marco Lupidi, Adrian T. Fung, Pierre-Henry Gabrielle, Ermete Giancipoli, Voraporn Chaikitmongkol, Mali Okada, Inês Laíns, Ana Rita Santos, Paradee Kunavisarut, Anna Sala-Puigdollers, Jay Chhablani, Malgorzata Ozimek, Assaf Hilely, Jan Darius Unterlauft, Anat LoewensteinMatias Iglicki, Matus Rehak, International Retina Group

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Abstract

Aims: To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting.

Methods: A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) > 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography.

Results: A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss < 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (- 4.2 vs. - 7.8 letters, p = 0.013). In eyes in which treatment was initiated at baseline (n = 102), treatment with 8-12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (- 0.3 ± 3.6 letters vs. - 3.8 ± 6.2 letters, p = 0.003).

Conclusion: In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.

Original language	English
Pages (from-to)	777-784
Number of pages	8
Journal	Acta Diabetologica
Volume	56
Issue number	7
DOIs	https://doi.org/10.1007/s00592-019-01310-z
Publication status	Published - Jul 2019

Bibliographical note

Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

Anti-VEGF therapy
Diabetic macular edema
Good visual acuity
Intravitreal therapy
Macular laser
Observation

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10.1007/s00592-019-01310-z

Publisher version (open access)Final published version, 574 KBLicence: CC BY

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Busch, C., Fraser-Bell, S., Zur, D., Rodríguez-Valdés, P. J., Cebeci, Z., Lupidi, M., Fung, A. T., Gabrielle, P.-H., Giancipoli, E., Chaikitmongkol, V., Okada, M., Laíns, I., Santos, A. R., Kunavisarut, P., Sala-Puigdollers, A., Chhablani, J., Ozimek, M., Hilely, A., Unterlauft, J. D., ... International Retina Group (2019). Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study. Acta Diabetologica, 56(7), 777-784. https://doi.org/10.1007/s00592-019-01310-z

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title = "Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study",

abstract = "Aims: To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting.Methods: A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) > 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography.Results: A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss < 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (- 4.2 vs. - 7.8 letters, p = 0.013). In eyes in which treatment was initiated at baseline (n = 102), treatment with 8-12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (- 0.3 ± 3.6 letters vs. - 3.8 ± 6.2 letters, p = 0.003).Conclusion: In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.",

keywords = "Anti-VEGF therapy, Diabetic macular edema, Good visual acuity, Intravitreal therapy, Macular laser, Observation",

author = "Catharina Busch and Samantha Fraser-Bell and Dinah Zur and Rodr{\'i}guez-Vald{\'e}s, {Patricio J.} and Zafer Cebeci and Marco Lupidi and Fung, {Adrian T.} and Pierre-Henry Gabrielle and Ermete Giancipoli and Voraporn Chaikitmongkol and Mali Okada and In{\^e}s La{\'i}ns and Santos, {Ana Rita} and Paradee Kunavisarut and Anna Sala-Puigdollers and Jay Chhablani and Malgorzata Ozimek and Assaf Hilely and Unterlauft, {Jan Darius} and Anat Loewenstein and Matias Iglicki and Matus Rehak and {International Retina Group}",

note = "Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.",

year = "2019",

month = jul,

doi = "10.1007/s00592-019-01310-z",

language = "English",

volume = "56",

pages = "777--784",

journal = "Acta Diabetologica",

issn = "0940-5429",

publisher = "Springer, Springer Nature",

number = "7",

}

Busch, C, Fraser-Bell, S, Zur, D, Rodríguez-Valdés, PJ, Cebeci, Z, Lupidi, M, Fung, AT, Gabrielle, P-H, Giancipoli, E, Chaikitmongkol, V, Okada, M, Laíns, I, Santos, AR, Kunavisarut, P, Sala-Puigdollers, A, Chhablani, J, Ozimek, M, Hilely, A, Unterlauft, JD, Loewenstein, A, Iglicki, M, Rehak, M & International Retina Group 2019, 'Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study', Acta Diabetologica, vol. 56, no. 7, pp. 777-784. https://doi.org/10.1007/s00592-019-01310-z

TY - JOUR

T1 - Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity

T2 - the OBTAIN study

AU - Busch, Catharina

AU - Fraser-Bell, Samantha

AU - Zur, Dinah

AU - Rodríguez-Valdés, Patricio J.

AU - Cebeci, Zafer

AU - Lupidi, Marco

AU - Fung, Adrian T.

AU - Gabrielle, Pierre-Henry

AU - Giancipoli, Ermete

AU - Chaikitmongkol, Voraporn

AU - Okada, Mali

AU - Laíns, Inês

AU - Santos, Ana Rita

AU - Kunavisarut, Paradee

AU - Sala-Puigdollers, Anna

AU - Chhablani, Jay

AU - Ozimek, Malgorzata

AU - Hilely, Assaf

AU - Unterlauft, Jan Darius

AU - Loewenstein, Anat

AU - Iglicki, Matias

AU - Rehak, Matus

AU - International Retina Group

N1 - Copyright the Author(s) 2019. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2019/7

Y1 - 2019/7

N2 - Aims: To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting.Methods: A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) > 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography.Results: A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss < 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (- 4.2 vs. - 7.8 letters, p = 0.013). In eyes in which treatment was initiated at baseline (n = 102), treatment with 8-12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (- 0.3 ± 3.6 letters vs. - 3.8 ± 6.2 letters, p = 0.003).Conclusion: In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.

AB - Aims: To describe and compare the functional and anatomical outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting.Methods: A 12-month, retrospective, multicenter, observational cohort study, including DME patients with baseline visual acuity (VA) ≤ 0.1 logMAR (≥ 20/25 Snellen) and central subfield thickness (CST) > 250 µm with intra- and/or subretinal fluid seen on optical coherence tomography.Results: A total of 249 eyes were included, of which 155 were treated and 94 were non-treated during follow-up. Most eyes maintained vision (VA gain or VA loss < 5 letters) at 12 months (treated: 58.1%; non-treated: 73.4%). In non-treated eyes with stable VA within the first 6 months, VA was maintained throughout the follow-up in most cases (86.3%). In non-treated eyes with VA loss ≥ 5 letters within 6 months (36.7%), further observation led to worse visual outcome than treatment (- 4.2 vs. - 7.8 letters, p = 0.013). In eyes in which treatment was initiated at baseline (n = 102), treatment with 8-12 anti-VEGF injections led to better visual outcome compared to treatment with less injections (- 0.3 ± 3.6 letters vs. - 3.8 ± 6.2 letters, p = 0.003).Conclusion: In a real-world setting, the majority of DME patients with very good VA maintained vision at 12 months, regardless of whether the DME was treated or not. This study supports close observation of eyes with DME and very good VA with consideration of treatment when a one line drop in vision is observed.

KW - Anti-VEGF therapy

KW - Diabetic macular edema

KW - Good visual acuity

KW - Intravitreal therapy

KW - Macular laser

KW - Observation

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U2 - 10.1007/s00592-019-01310-z

DO - 10.1007/s00592-019-01310-z

M3 - Article

C2 - 30903434

SN - 0940-5429

VL - 56

SP - 777

EP - 784

JO - Acta Diabetologica

JF - Acta Diabetologica

IS - 7

ER -

Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study

Abstract

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Keywords

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