EFFECT OF ORAL LAMIVUDINE VERSUS PLACEBO IN DIABETIC MACULAR EDEMA: A RANDOMIZED CLINICAL TRIAL

Abstract

Purpose : The Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol T study demonstrated that monthly intravitreous injections of anti-vascular endothelial growth factor (VEGF) agents are effective in treating diabetic macular edema (DME) involving the center of the macula (center-involved DME [CI-DME]). These expensive and often burdensome injections also carry risks of vision-threatening complications. Whether an oral therapy that avoids these issues can improve visual acuity in DME is unknown. We sought to compare the efficacy of lamivudine, an orally administered inflammasome inhibitor, to oral placebo for improving visual acuity in patients with CI-DME and poor vision.

Methods : In this double-blind, randomized trial, we assigned 24 adults (mean age, 62.7±5.9 years) with diabetic macular edema involving the macular center and visual-acuity letter score less than 69 to receive oral lamivudine at a dose of 150 mg twice daily (10 participants; 16 eyes) or oral placebo (14 participants; 21 eyes). The study drugs were administered for 8 weeks. All participants were assigned to receive intravitreous bevacizumab at a dose of 1.25 mg at week 4. The primary outcome was the mean change in visual acuity. In addition, comparisons to aflibercept, bevacizumab, and ranibizumab were made using synthetic controls from the DRCR.net Protocol T study.

Results : From baseline to 4 weeks, mean visual-acuity letter score improved by 9.8 with lamivudine and decreased by 1.8 with placebo (P<0.001). At 8 weeks, the mean visual-acuity letter score improved by 16.9 with lamivudine and bevacizumab and by 5.3 with placebo and bevacizumab (P<0.001). Lamivudine was more effective at improving vision than bevacizumab or ranibizumab (P<0.05), and non-inferior to aflibercept (P=0.5). Only mild systemic adverse events were reported and were not significantly different between lamivudine and placebo groups.

Conclusions : Among patients with CI-DME and visual-acuity letter score less than 69, oral lamivudine improved vision.

This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.