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BCVA as an Early Indicator in Treat-and-Extend Management of DME: READ-3 Post-hoc Analysis

Khowaja, A. H.; Janjua, K.; Afridi, R.; Fazal, Z. Z.; Shaik, M. A. S.; Ahmed, M. I.; Halim, M. S.; Nguyen, Q. D.; Sepah, Y.

2025-07-15 ophthalmology
10.1101/2025.07.13.25331469 medRxiv
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PurposeTo determine whether significant changes in best-corrected visual acuity (BCVA) precede or coincide with increases in central retinal thickness (CRT) in diabetic macular edema (DME) during a treat-and-extend (T&E) regimen following initial edema resolution. MethodsThis post-hoc analysis included 60 eyes (60 participants) from the READ-3 clinical trial that achieved CRT <250 {micro}m and were followed until edema recurrence. Following a six-month ranibizumab loading phase, patients were monitored through 24 months with as-needed retreatment. Significant changes were defined as [&ge;]4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters and [&ge;]30 {micro}m on time-domain optical coherence tomography (TD-OCT). The temporal relationship between functional (BCVA) and anatomical (CRT) changes was analyzed. ResultsMedian time to edema resolution was 10 months (IQR: 6-16) and to recurrence was 3 months (IQR: 2-3). 52 eyes (86.7%) had functional worsening and 43 (71.7%) had anatomical worsening. In 39 eyes exhibiting both types of deterioration, changes were concurrent in 24 (61.5%). Vision loss preceded anatomical recurrence (BCVA-led) in 23.1% of eyes, with a lead time of 1-4 months. Conversely, anatomical thickening preceded vision loss (OCT-led) in 15.4% of eyes, by a maximum of 2 months. ConclusionsBCVA fluctuations frequently mirror CRT changes and can precede structural relapse, suggesting that BCVA is a sensitive indicator of DME activity. In resource-limited settings, BCVA may allow for earlier detection of recurrence than OCT alone. Translational RelevanceFunctional vision loss can precede structural edema recurrence, supporting the potential for home-based BCVA monitoring as a validated bridge for timely clinical intervention in DME.

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