Trial reportMed (New York, N.Y.)2025
Oral lamivudine in diabetic macular edema: A randomized, double-blind, placebo-controlled clinical trial.
Trial report in Med (New York, N.Y.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
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Authors and funding
14 authors.
Funding
Abstract
backgroundDiabetic macular edema (DME) affects millions worldwide. Intraocular injections of expensive anti-vascular endothelial growth factor (VEGF) inhibitors associated with complications are standard therapy. Lamivudine, an inexpensive oral drug, inhibits inflammasome activation, which is implicated in DME. This randomized, double-blind, placebo-controlled trial compared oral lamivudine to placebo for improving visual acuity in center-involved DME (CI-DME).
methodsTwenty-four adults enrolled between February 2022 and September 2023 with 1 or 2 eyes with CI-DME and a best-corrected visual acuity (BCVA) of less than 69 letters (Brazilian Registry of Clinical Trials RBR-87b6r5s) were randomized to lamivudine (150 mg twice daily; 10 participants; 16 eyes) or placebo (14 participants; 21 eyes) for 8 weeks. Participants were assigned intravitreous bevacizumab (1.25 mg) at week 4. Co-primary outcomes were mean changes in BCVA from baseline to weeks 4 and 8. Comparisons to anti-VEGF drugs used synthetic controls from DRCR.net Protocol T. Secondary outcomes included retinal thickness and adverse events.
findingsAt 4 weeks, BCVA improved 9.8 letters with lamivudine and decreased 1.8 letters with placebo (p < 0.001). At 8 weeks, BCVA improved 16.9 letters with lamivudine and bevacizumab and 5.3 letters with placebo and bevacizumab (p < 0.001). Lamivudine was associated with greater BCVA improvement than bevacizumab or ranibizumab (p < 0.05) and was not different from aflibercept (p = 0.5). There was no significant difference in retinal thickness or adverse events between groups.
conclusionsLamivudine, an oral inflammasome inhibitor, significantly improved vision in patients with CI-DME.
fundingThis work was supported by Universidade Federal de São Paulo, Latinofarma, UVA SIF, and NIH.
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