Risk of VA loss link found between DME eyes initially treated and observed

New research has found a correlation between the risk of 5-letter visual acuity (VA) loss at 24 months for eyes with clinically significant diabetic macular edema (CSDME) and good VA initially treated and eyes that were initially observed in routine clinical practice.

Despite this, investigators report that initially observed eyes have a significantly greater loss of adjusted mean change in VA—with more than 80% of these patients needing treatment over the study period.

Lead author Pierre-Henry Gabrielle, MD , MSc, of Sydney Medical School, Discipline of Ophthalmology, Save Sight Institute, University of Sydney, wrote in the study—published in Acta Ophthalmologica—that the results suggest a delay in treatment initiation leads to the need for more intensive treatment and monitoring to maintain good vision.

“The inconvenience of starting treatment early may thus be offset by reducing the burden of long-term visits for patients and physicians,” Gabrielle said.

With a current lack of data on how best to treat eyes with DME and good vision, the study sought to compare visual outcomes of eyes after initial treatment versus baseline observation with possible treatment following the first 4 months of routine practice.

The study—a retrospective analysis of data from the Fight Retinal Blindness! Project—included treatment-naîve eyes with clinically significant DME that met the following criteria:


edema within 500 μm of the center of the fovea

>1 disc area of swelling with good VA (baseline VA ≥79 letters read on a log MAR chart or 20/25 Snellen equivalent)

≥24 months of follow-up

Included for consideration were all eligible eyes with treatment-naîve clinically significant DME and good vision at baseline from January 2010 to March 2018. Additionally, vascular endothelium (VEGF), steroid implant and/or macular laser photocoagulation at baseline were defined as “initially treated eyes,” the investigators reported.

Additionally, initially observed eyes were identified as eligible eyes that were observed intuitively for at least 4 months—without received treatment.

The primary outcome for the study was the proportion of eyes with ≥5 letter VA loss from baseline at 24 months, with secondary outcomes including mean change in VA and CST from baseline. Inclusion and the proportion of eyes with a VA ≥ 84 letters (Snellen equivalent of 20/20), according to investigators.

In total, 150 treatment-naîve eyes with clinically significant DME were identified in 130 patients, with the average age being 60 years old and 32% of patients being female.

According to data, the percentage of eyes with ≥5 letter VA loss at 24 months from baseline to initial treatment was 65% vs. 42% (odds ratio [OR]1.6; P = 0.39). Further, eyes in the initial observation group were more likely to have VA loss of 10 and 15 letters at 24 months (OR = 4.6; P = 0.022 and OR = 18.5, P = 0.065, respectively).

Additionally, 29% of eyes had VA ≥ 84 letters at 24 months with the initial observation and 35% with the initial treatment. Researchers noted that at least 1 intravitreal injection was administered to 66% of eyes in the initial observation group over 24 months, while 20% received a macular laser and 13% received both.

Investigators concluded:

“Initiating treatment may be a better management option for good vision DME in the case of patients with weak adherence and compliance since it decreases the risk of visual loss and reduces the patient’s management burden from diabetes and associated comorbidities. The development of less invasive or more durable treatments may further tilt the balance in favour of initiating treatment earlier.”


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