학술논문
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
Original Research
Original Research
Document Type
Report
Author
Source
Ophthalmology and Therapy. June 2023, Vol. 12 Issue 3, p1671, 22 p.
Subject
Language
English
Abstract
Author(s): Laurent Kodjikian [sup.1] [sup.2] , Cécile Delcourt [sup.3] , Catherine Creuzot-Garcher [sup.4] , Pascale Massin [sup.5] , John Conrath [sup.6] , Marie-Ève Velard [sup.7] , Thibaut Lassalle [sup.8] , [...]
Introduction To evaluate real-world efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in diabetic macular edema (DME) in France. Methods In 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 [greater than or equal to] 20% from baseline at each visit, patients (%) with DME resolution (per investigator judgement), and adverse events (AEs). Results Of 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 [greater than or equal to] 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 [greater than or equal to] 10-letter BCVA gains from baseline. The mean maximum CRT reduction from baseline was -146.4 [micro]m; 61.4% (week 6) and 36.0% (month 6) of patients had CRT reductions [greater than or equal to] 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. Conclusions LOUVRE 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 Identifier NCT03003416.
Introduction To evaluate real-world efficacy, safety, and treatment patterns with the dexamethasone intravitreal implant (DEX) in diabetic macular edema (DME) in France. Methods In 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 [greater than or equal to] 20% from baseline at each visit, patients (%) with DME resolution (per investigator judgement), and adverse events (AEs). Results Of 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 [greater than or equal to] 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 [greater than or equal to] 10-letter BCVA gains from baseline. The mean maximum CRT reduction from baseline was -146.4 [micro]m; 61.4% (week 6) and 36.0% (month 6) of patients had CRT reductions [greater than or equal to] 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. Conclusions LOUVRE 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 Identifier NCT03003416.