Watchful waiting, accepted as proper management of patients with diabetic macular edema (DME) and good baseline visual acuity (VA), may not be the best approach in a select subset of patients.
In patients who have hyperreflective foci (HRF), a disorganization of the inner retina layers (DRIL), or a disruption of the ellipsoid zone (EZ) on spectral-domain optical coherence tomography (SD-OCT), early treatment may reduce the risk of future VA loss, German researchers reported.1
It appears that “there are patients with a higher risk for VA loss during observation than others,” said Catharina Busch, MD, at University Hospital Leipzig in Leipzig, Germany. “We might have to consider that the conclusion we got from Protocol V and the OBTAIN studies—that close observation is proper management—does not apply for all patients. There might be patients in which an immediate treatment might provide better long-term results.”
Clues from SD-OCT. The current findings are based on a subanalysis of OBTAIN, a 12-month retrospective cohort study that considered charts of 210 patients (249 eyes) with baseline VA equal to or worse than 20/25 and center-involving DME.2
For this secondary analysis, the researchers included observed eyes and eyes that received anti-VEGF treatment at baseline. They focused on the observed eyes (n = 147), of which 21% (n = 32) experienced VA loss of 10 or more letters during 12 months of follow-up. In the presence of one SD-OCT feature—HRF, DRIL, or EZ disruption—the odds of experiencing VA loss of at least 10 letters during observation increased 2.7- to 3.2-fold.
When all three features were present, the risk for future VA loss of 10 or more letters during observation increased up to 47% over baseline. When patients were treated immediately at baseline, the risk of future VA loss was reduced to 26% during follow-up.
The presence of subretinal fluid was not a factor.
More study needed. It should be noted that these findings did not reach statistical significance, perhaps due to the small sample size. Moreover, as with the original OBTAIN study, this was a retrospective evaluation.
But the findings suggest the need for further studies in bigger cohorts of patients to evaluate whether an immediate treatment in these high-risk patients is superior to observation or not, Dr. Busch said.
In the meantime, she suggested that clinicians consider the presence or absence of DRIL, HRF, and EZ disruption when deciding whether to treat immediately or closely observe. “Our study changed my personal awareness. If risk features are present, I adapt my control intervals and decide for treatment earlier.”
1 Busch C et al. Acta Ophthalmol. Published online March 1, 2020.
2 Busch C et al. Acta Diabetol. 2019;56(7):777-784.
Relevant financial disclosures—Dr. Busch: None.
For full disclosures and the disclosure key, see below.
Full Financial Disclosures
Dr. Busch None.
Dr. Li Wuhan Neurophth Biotechnology: S.
Dr. Mansouri Alcon: L, Allergan: C,L; Bayer: S; Implandata: C; Glaukos: S; Novartis: L; New World Medical: C,L; Optovue: L,S; Santen: L,S; Sensimed: C; Thea: L; Topcon: L,S.
Dr. Sim Allergan: C; Bayer: C; Big Picture Eye Health: C; Haag Streit: C; Novartis: C.
||Consultant fee, paid advisory boards, or fees for attending a meeting.
||Employed by a commercial company.
||Lecture fees or honoraria, travel fees or reimbursements when speaking at the invitation of a commercial company.
||Equity ownership/stock options in publicly or privately traded firms, excluding mutual funds.
||Patents and/or royalties for intellectual property.
||Grant support or other financial support to the investigator from all sources, including research support from government agencies (e.g., NIH), foundations, device manufacturers, and/or pharmaceutical companies.
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