July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
Observation versus Treatment in Diabetic Macular Edema with Very Good Visual Acuity – The OBTAIN study
Author Affiliations & Notes
  • Catharina Busch
    University Hospital Leipzig, Leipzig, Germany
  • Matias Iglicki
    Private Retina Service, University of Buenos Aires, Buenos Aires, Argentina
  • Samanta Fraser-Bell
    Department of Ophthalmology, Sydney University, Sydney, New South Wales, Australia
  • Dinah Zur
    Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
    Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
  • Patricio J. Rodríguez-Valdés
    Instituto de Oftalmología y Ciencias Visuales, Escuela de Medicina, Tecnológico de Monterrey, Monterrey, Mexico
  • Zafer Cebeci
    Department of Ophthalmology, Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey
  • Marco Lupidi
    Department of Biomedical and Surgical Sciences, Section of Ophthalmology, University of Perugia, Perugia, Italy
  • Adrian Tien-Chin Fung
    Department of Ophthalmology, Sydney University, Sydney, New South Wales, Australia
    Department of Ophthalmology, Westmead Hospital, Sydney, New South Wales, Australia
  • Pierre-Henry Gabrielle
    Department of Ophthalmology, Dijon University Hospital, Dijon, France
    Center for Taste and Feeding Behaviour, Dijon, France
  • Ermete Giancipoli
    Department of Surgical, Microsurgical and Medical Sciences, Eye Clinic, University of Sassari, Sassari, Italy
  • Voraporn Chaikitmongkol
    Retina Division, Department of Ophthalmology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand
  • Mali Okada
    Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia
  • Jay Chhablani
    L.V. Prasad Eye Institute, Banjara Hills, Hyderabad, India
  • Anat Loewenstein
    Division of Ophthalmology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
    Incumbent, Sydney A. Fox chair in Ophthalmology, Tel Aviv University, Tel Aviv, Israel
  • Matus Rehak
    University Hospital Leipzig, Leipzig, Germany
  • Footnotes
    Commercial Relationships   Catharina Busch, None; Matias Iglicki, None; Samanta Fraser-Bell, None; Dinah Zur, None; Patricio J. Rodríguez-Valdés, None; Zafer Cebeci, None; Marco Lupidi, None; Adrian Fung, None; Pierre-Henry Gabrielle, None; Ermete Giancipoli, None; Voraporn Chaikitmongkol, None; Mali Okada, None; Jay Chhablani, None; Anat Loewenstein, None; Matus Rehak, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 2600. doi:
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      Catharina Busch, Matias Iglicki, Samanta Fraser-Bell, Dinah Zur, Patricio J. Rodríguez-Valdés, Zafer Cebeci, Marco Lupidi, Adrian Tien-Chin Fung, Pierre-Henry Gabrielle, Ermete Giancipoli, Voraporn Chaikitmongkol, Mali Okada, Jay Chhablani, Anat Loewenstein, Matus Rehak; Observation versus Treatment in Diabetic Macular Edema with Very Good Visual Acuity – The OBTAIN study . Invest. Ophthalmol. Vis. Sci. 2019;60(9):2600.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : To describe and compare the functional and anatomical 12-month outcomes of untreated and treated diabetic macular edema (DME) in eyes with very good baseline visual acuity (VA) in a real-world setting.

Methods : To be included in this retrospective, multicenter, observational cohort study, eyes were required to have DME 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. Patients charts were reviewed for demographic data and baseline characteristics, prior DME treatment, VA and CST at baseline, month 3, 6, 9, 12, and DME treatment during the 12-month follow-up. Main outcome measures were change in VA and CST at 12 months in treaed vs. observed eyes. Statistical analyses were performed by generalized estimating equations procedure.

Results : A total of 249 eyes from 211 patients were included, of which 155 eyes were treated during follow up and 94 eyes were observed. The majority of eyes maintained vision (VA loss < 5 letters or VA gain) at 12 months (treated: 58.1%; observed: 73.4%). In the vast majority of observed eyes (63/73 eyes, 86.3%) with stable VA within the first 6 months, VA was maintained throughout the follow-up (-0.1 ± 3.8 letters, p=0.889). In 54 of 147 eyes (36.7%), that were initially observed, a VA loss ≥ 5 letters within 6 months was experienced. Within those eyes, further observation (n=21) led to worse visual outcome than treatment (n=33) (-4.2 vs. -7.8 letters, p=0.013). In eyes in which treatment was initiated at baseline (n=102), intensive treatment (8-12 anti-VEGF injections during the 12 months follow up) led to CST improvement (-85.9 vs.+11.3 µm, p=0.003), but there was no significant difference in visual acuity (-0.3 vs. -1.8 letters, p=0.137) compared with observation.

Conclusions : 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.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

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