Prospective, Observational, Multicenter, Real-World Study of the Efficacy, Safety, and Pattern of Use of the Dexamethasone Intravitreal Implant in Diabetic Macular Edema in France: Short-Term Outcomes of LOUVRE 3

IntroductionTo evaluate real-world efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in diabetic macular edema (DME) in France.MethodsIn this prospective, multicenter, observational, noncomparative, post-reimbursement study, consecutively enrolled patients with DME had a baseline evaluation on day 0. Those treated with DEX on day 0 were to be reevaluated at week 6 and months 6, 12, 18, and 24. DEX retreatment and/or alternative therapies were allowed during follow-up. The primary outcome measure was the maximum best corrected visual acuity (BCVA) gain from baseline during follow-up. Secondary outcome measures included time to maximum BCVA gain, patients (%) with prespecified BCVA gains from baseline at each visit, maximum central retinal thickness (CRT) reduction from baseline, patients (%) with CRT reduction >= 20% from baseline at each visit, patients (%) with DME resolution (per investigator judgement), and adverse events (AEs).ResultsOf 112 patients/eyes with DME for 3.5 years (mean) at baseline, 80 (including 86.1% previously treated) received DEX on day 0 and were analyzed for efficacy. Early study termination precluded collection of >= 12-month efficacy data. Patients received 1.4 DEX injections over 8.3 months (averages). The maximum BCVA gain from baseline was 3.6 letters, reached after 77.2 days (averages); 24.6% (week 6) and 15.0% (month 6) of patients experienced >= 10-letter BCVA gains from baseline. The mean maximum CRT reduction from baseline was -146.4 mu m; 61.4% (week 6) and 36.0% (month 6) of patients had CRT reductions >= 20% from baseline, and 68.1% reported DME resolution at least once during follow-up. Ocular hypertension (n = 8, 12.1%) was the most frequent treatment-related AE.ConclusionsLOUVRE 3 confirmed that DEX improves BCVA and CRT, even in a patient population that had predominantly received DEX before enrollment in the study, and showed that DME resolution was observed during follow-up. DEX tolerability was consistent with published data, supporting treatment benefits in DME.ClinicalTrials.gov IdentifierNCT03003416.

Automated summary

This study aimed to evaluate the real-world efficacy, safety, and treatment patterns of the dexamethasone intravitreal implant (DEX) in patients with diabetic macular edema (DME) in France. The results showed that DEX improved visual acuity and central retinal thickness in patients with DME, and resolution of DME was observed during follow-up, supporting the treatment benefits of DEX in DME.