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.

Subthreshold yellow laser for fovea-involving diabetic macular edema in a series of patients with good vision: effectiveness and safety of a fovea-sparing technique

“…CI-DME with good VA is a controversial clinical setting because of the disadvantages of the most commonly applied treatment strategies [3]: observation, which may lead to further deterioration with VA loss, and intravitreal therapy, which has a high cost and potential complications such as endophthalmitis that, although rare [15], is especially devastating when treating asymptomatic patients.…”

“…Recently, DRCR.net has assessed whether anti-VEGF therapies would be useful in this situation versus observation and laser photocoagulation [2]. However, anti-VEGF is still invasive and expensive, so at least to the present day, close observation has become the standard of care, as the retinal damage caused by conventional lasers is becoming increasingly unacceptable to patients and retinal specialists [3,4]. The use of a subthreshold laser (STL), which does not cause cicatricial or tissue-changing effects, is considered a safe technique to work around and even on the fovea [5][6][7][8][9] since no clinically visible effects appear on the fundus, optical coherence tomography (OCT) or autofluorescence (AF), the latter being especially sensitive to any disturbances/damages in the retinal pigment epithelium (RPE) [10].…”

Baseline predictors for visual acuity loss during observation in diabetic macular oedema with good baseline visual acuity

“…The study procedures have been reported previously and are summarized briefly (Busch et al 2019). Institutional review board (IRB) approval was obtained through the individual IRBs at the participating institutes for a retrospective consecutive chart review.…”

New Findings From Diabetic Retinopathy Clinical Research Retina Network Protocol V Confirm a Role for Focal Laser Photocoagulation or Observation for Eyes With Center-Involved Diabetic Macular Edema and Good Visual Acuity

“…However real world data from the OBTAIN study, which included patients with excellent VA, has reported that followup is maintained in untreated eyes with DME over a period of 1 year. 6 Protocol V now gives us the confidence to manage our patients with DME and excellent VA conservatively at least until there is documented reduction in VA. Such a management strategy would avoid potentially unnecessary introduction of anti-VEGF therapies at a stage of disease which may be amenable to alternative noninvasive strategies such as good systemic control.…”