Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)
Louvre 3
1 other identifier
observational
115
1 country
25
Brief Summary
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2017
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2016
CompletedFirst Posted
Study publicly available on registry
December 28, 2016
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2018
CompletedMarch 14, 2019
March 1, 2019
1.2 years
December 22, 2016
March 12, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Baseline to Month 24
Secondary Outcomes (21)
Time to Achieve Maximum Gain in BCVA
24 Months
Change from Baseline in BCVA
Baseline, Week 6, Months 6, 12, 18 and 24
Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline
Baseline, Week 6, Month 6, 12, 18 and 24
Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline
Baseline, Week 6, Month 6, 12, 18 and 24
Change from Baseline in Retinal Thickness
Baseline, Month 24
- +16 more secondary outcomes
Study Arms (1)
OZURDEX®
Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.
Interventions
Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
Eligibility Criteria
Patients treated with OZURDEX® in clinical practice.
You may qualify if:
- Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.
You may not qualify if:
- Patient not residing in metropolitan France.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (25)
Centre MGM
Aix-en-Provence, 13090, France
Ballanger
Aulnay-sous-Bois, 93600, France
CH BLOIS
Blois, 41016, France
CH Avicennes Bobigny
Bobigny, 93000, France
Centre Rétine Gallien à Bordeaux
Bordeaux, 33000, France
CHU Bordeaux
Bordeaux, 33000, France
CHU Brest
Brest, 29200, France
CHI Créteil
Créteil, 94000, France
CH SCORFF - Lorient
Lorient, 56100, France
Hopital De La Croix Rousse
Lyon, 69004, France
Clinique Monticelli
Marseille, 13008, France
Hopital de la Timone
Marseille, 13385, France
CHR Annecy
Metz-Tessy, 74370, France
CHU Pasteur 2
Nice, 06001, France
Chno 1520
Paris, 75012, France
Hopital Saint Joseph
Paris, 75014, France
Fondation Rothschild
Paris, 75019, France
Lariboisiere
Paris, 75475, France
COCHIN
Paris, 75679, France
Hopital Poissy
Poissy, 78300, France
Hôpital de La Milétrie Poitiers
Poitiers, 86021, France
Hopital Saint Germain en Laye
Saint-Germain-en-Laye, 78100, France
Centre OPHTA.Kervision
Saint-Herblain, 44800, France
Maison Rouge
Strasbourg, 67000, France
Chu Toulouse
Toulouse, 31059, France
Related Publications (1)
Kodjikian L, Delcourt C, Creuzot-Garcher C, Massin P, Conrath J, Velard ME, Lassalle T, Pinchinat S, Dupont-Benjamin L. 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. Ophthalmol Ther. 2023 Jun;12(3):1671-1692. doi: 10.1007/s40123-023-00662-8. Epub 2023 Mar 26.
PMID: 36967448DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nathalie Mesnard
Allergan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2016
First Posted
December 28, 2016
Study Start
October 19, 2017
Primary Completion
December 19, 2018
Study Completion
December 19, 2018
Last Updated
March 14, 2019
Record last verified: 2019-03