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
Abstract 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...
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| Format: | Article |
| Language: | English |
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Adis, Springer Healthcare
2023-03-01
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| Series: | Ophthalmology and Therapy |
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| Online Access: | https://doi.org/10.1007/s40123-023-00662-8 |
| _version_ | 1797832132903567360 |
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| author | Laurent Kodjikian Cécile Delcourt Catherine Creuzot-Garcher Pascale Massin John Conrath Marie-Ève Velard Thibaut Lassalle Sybil Pinchinat Laure Dupont-Benjamin |
| author_facet | Laurent Kodjikian Cécile Delcourt Catherine Creuzot-Garcher Pascale Massin John Conrath Marie-Ève Velard Thibaut Lassalle Sybil Pinchinat Laure Dupont-Benjamin |
| author_sort | Laurent Kodjikian |
| collection | DOAJ |
| description | Abstract 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 ≥ 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 ≥ 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 µm; 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. 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. |
| first_indexed | 2024-04-09T14:03:58Z |
| format | Article |
| id | doaj.art-067dd3a1b7f841b4b7baec5a0d299690 |
| institution | Directory Open Access Journal |
| issn | 2193-8245 2193-6528 |
| language | English |
| last_indexed | 2024-04-09T14:03:58Z |
| publishDate | 2023-03-01 |
| publisher | Adis, Springer Healthcare |
| record_format | Article |
| series | Ophthalmology and Therapy |
| spelling | doaj.art-067dd3a1b7f841b4b7baec5a0d2996902023-05-07T11:07:45ZengAdis, Springer HealthcareOphthalmology and Therapy2193-82452193-65282023-03-011231671169210.1007/s40123-023-00662-8Prospective, 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 3Laurent Kodjikian0Cécile Delcourt1Catherine Creuzot-Garcher2Pascale Massin3John Conrath4Marie-Ève Velard5Thibaut Lassalle6Sybil Pinchinat7Laure Dupont-Benjamin8La Croix-Rousse Hospital, University Hospital of LyonUniversité de Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 1219Centre Hospitalier de L’Université de DijonCentre Hospitalier de L’Université de LariboisièreCentre Monticelli-ParadisAllergan, an AbbVie CompanyAxonal-BiostatemAxonal-BiostatemAllergan, an AbbVie CompanyAbstract 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 ≥ 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 ≥ 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 µm; 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. 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.https://doi.org/10.1007/s40123-023-00662-8DexamethasoneDiabetic macular edemaFranceImplantIntravitrealReal-world evidence |
| spellingShingle | Laurent Kodjikian Cécile Delcourt Catherine Creuzot-Garcher Pascale Massin John Conrath Marie-Ève Velard Thibaut Lassalle Sybil Pinchinat Laure Dupont-Benjamin 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 Ophthalmology and Therapy Dexamethasone Diabetic macular edema France Implant Intravitreal Real-world evidence |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Dexamethasone Diabetic macular edema France Implant Intravitreal Real-world evidence |
| url | https://doi.org/10.1007/s40123-023-00662-8 |
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