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, 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

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.

Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Mean change in visual acuity (a) and central subfield thickness (b, CST) over 12-month follow-up in eyes that were initially non-treated experiencing a VA loss ≥ 5 letters. Data are mean ± 95% confidence interval. M0 baseline, month 0
Fig. 2
Fig. 2
Mean change in visual acuity (a) and central subfield thickness (b, CST) over 12-month follow-up in eyes stratified for number of anti-VEGF injections. Data are mean ± 95% confidence interval. VEGF vascular endothelial growth factor, M0 baseline, month 0

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