Evidence mapPaperPMID 40436012Full record

Trial reportMed (New York, N.Y.)2025

Oral lamivudine in diabetic macular edema: A randomized, double-blind, placebo-controlled clinical trial.

Felipe Pereira, Joseph Magagnoli, Meenakshi Ambati, Talita Fernandes de Oliveira, Juliana Angélica Estevão de Oliveira, Vinicius Oliveira Pesquero, Lucas Zago Ribeiro, Dante Akira Kondo Kuroiwa, Fernando Korn Malerbi, Sergio Atala Dib and 4 more

Abstract readRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Felipe PereiraDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Joseph MagagnoliDepartment of Clinical Pharmacy and Outcomes Sciences, College of Pharmacy, University of South Carolina, Columbia, SC, USA.
Meenakshi AmbatiYale University, New Haven, CT, USA.
Talita Fernandes de OliveiraDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Juliana Angélica Estevão de OliveiraDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Vinicius Oliveira PesqueroDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Lucas Zago RibeiroDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Dante Akira Kondo KuroiwaDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Fernando Korn MalerbiDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Sergio Atala DibDepartamento de Endocrinologia - Centro de Diabetes of Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, Brazil.
Nilva Bueno MoraesDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Michel Eid FarahDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Eduardo Buchele RodriguesDepartamento de Oftalmologia e Ciências Visuais, Universidade Federal de São Paulo, São Paulo, Brazil.
Jayakrishna AmbatiCenter for Advanced Vision Science and Department of Ophthalmology, University of Virginia School of Medicine, Charlottesville, VA, USA; Department of Pathology, University of Virginia School of Medicine, Charlottesville, VA, USA; Department of Microbiology, Immunology, and Cancer Biology, University of Virginia School of Medicine, Charlottesville, VA, USA. Electronic address: ja9qr@virginia.edu.

Funding

Cytosolic SINE retrotransposable element cDNA and mitochondrial DNA in aging retinaR01AG082748 · UNIVERSITY OF VIRGINIA · 2025 to 2025
$614k
Defining the role of SINE retrotransposons and inflammasome activation in Alzheimer's diseaseR01AG078892 · UNIVERSITY OF VIRGINIA · 2025 to 2025
$608k
Non-canonical inflammasome in activation in RPE degenerationR01EY029799 · NEI · UNIVERSITY OF VIRGINIA · PI Jayakrishna Ambati · 2022 to 2022
$564k
NEI NIH HHS R01 EY029799NEI NIH HHS R01 EY031039NIA NIH HHS R01 AG078892NIA NIH HHS R01 AG082748
6 · The paper itself

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.

Indexed as

Diabetic RetinopathyLamivudineMacular EdemaAdministration, OralAdultAgedAngiogenesis InhibitorsBevacizumabDouble-Blind MethodFemaleHumansIntravitreal InjectionsMaleMiddle AgedTreatment OutcomeVisual AcuityAngiogenesis InhibitorsBevacizumabLamivudineclinical trialdiabetic macular edemainflammasomelamivudineNRTITranslation to patients

Identifiers

PMID40436012
PMCPMC12354088

What Socratic holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.