PMID- 36967448
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230509
IS  - 2193-8245 (Print)
IS  - 2193-6528 (Electronic)
VI  - 12
IP  - 3
DP  - 2023 Jun
TI  - 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.
PG  - 1671-1692
LID - 10.1007/s40123-023-00662-8 [doi]
AB  - 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 microm; 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. GOV IDENTIFIER: 
      NCT03003416.
CI  - (c) 2023. The Author(s).
FAU - Kodjikian, Laurent
AU  - Kodjikian L
AUID- ORCID: 0000-0002-3908-6716
AD  - La Croix-Rousse Hospital, University Hospital of Lyon, 103 Grande Rue de La 
      Croix-Rousse, 69004, Lyon, France. kodjikian.laurent@wanadoo.fr.
AD  - UMR CNRS 5510 MATEIS INSA Lyon, Universite de Lyon Claude Bernard, Lyon, France. 
      kodjikian.laurent@wanadoo.fr.
FAU - Delcourt, Cecile
AU  - Delcourt C
AUID- ORCID: 0000-0002-2099-0481
AD  - Universite de Bordeaux, INSERM, Bordeaux Population Health Research Center, UMR 
      1219, Bordeaux, France.
FAU - Creuzot-Garcher, Catherine
AU  - Creuzot-Garcher C
AD  - Centre Hospitalier de L'Universite de Dijon, Dijon, France.
FAU - Massin, Pascale
AU  - Massin P
AD  - Centre Hospitalier de L'Universite de Lariboisiere, Paris, France.
FAU - Conrath, John
AU  - Conrath J
AUID- ORCID: 0000-0002-9382-2526
AD  - Centre Monticelli-Paradis, Marseille, France.
FAU - Velard, Marie-Eve
AU  - Velard ME
AD  - Allergan, an AbbVie Company, Courbevoie, France.
FAU - Lassalle, Thibaut
AU  - Lassalle T
AD  - Axonal-Biostatem, Castries, France.
FAU - Pinchinat, Sybil
AU  - Pinchinat S
AUID- ORCID: 0000-0002-5897-7346
AD  - Axonal-Biostatem, Castries, France.
FAU - Dupont-Benjamin, Laure
AU  - Dupont-Benjamin L
AUID- ORCID: 0000-0001-7748-0768
AD  - Allergan, an AbbVie Company, Courbevoie, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT03003416
PT  - Journal Article
DEP - 20230326
PL  - England
TA  - Ophthalmol Ther
JT  - Ophthalmology and therapy
JID - 101634502
PMC - PMC10164204
OTO - NOTNLM
OT  - Dexamethasone
OT  - Diabetic macular edema
OT  - France
OT  - Implant
OT  - Intravitreal
OT  - Real-world evidence
OT  - Visual acuity
COIS- Financial arrangements of the authors with companies whose products may be 
      related to the present report follow, as declared by the authors. Laurent 
      Kodjikian is a consultant for Allergan (an AbbVie company), Bayer, Laboratoires 
      Thea, Novartis, and Roche. Cecile Delcourt is a consultant for Allergan (an 
      AbbVie company), Bausch + Lomb, Laboratoires Thea, and Novartis. Catherine 
      Creuzot-Garcher is a consultant for AbbVie, Allergan (an AbbVie company), Bausch 
      + Lomb, Bayer, Horus Pharma, Novartis, and Laboratoires Thea. Pascale Massin is a 
      consultant for Allergan (an AbbVie company) and Novartis. John Conrath is a 
      consultant for Alcon, Alimera, Allergan (an AbbVie company), Bayer, Ellex, 
      Novartis, and Roche. Marie-Eve Velard and Laure Dupont-Benjamin are employees of 
      AbbVie Inc and may hold AbbVie stock/share options. Thibaut Lassalle was an 
      employee of Axonal-Biostatem (the contract research organization in charge of the 
      study) at the time the study was conducted; he is a current employee of Excelya. 
      Sybil Pinchinat is an employee of Axonal-Biostatem.
EDAT- 2023/03/27 06:00
MHDA- 2023/03/27 06:01
PMCR- 2023/03/26
CRDT- 2023/03/26 23:17
PHST- 2022/08/04 00:00 [received]
PHST- 2023/01/19 00:00 [accepted]
PHST- 2023/03/27 06:01 [medline]
PHST- 2023/03/27 06:00 [pubmed]
PHST- 2023/03/26 23:17 [entrez]
PHST- 2023/03/26 00:00 [pmc-release]
AID - 10.1007/s40123-023-00662-8 [pii]
AID - 662 [pii]
AID - 10.1007/s40123-023-00662-8 [doi]
PST - ppublish
SO  - Ophthalmol Ther. 2023 Jun;12(3):1671-1692. doi: 10.1007/s40123-023-00662-8. Epub 
      2023 Mar 26.