Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME) (Louvre 3)

March 12, 2019 updated by: Allergan
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

115

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Aix-En-Provence, France, 13090
        • Centre MGM
      • Aulnay-Sous-Bois, France, 93600
        • Ballanger
      • Blois, France, 41016
        • CH BLOIS
      • Bobigny, France, 93000
        • CH Avicennes Bobigny
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Bordeaux, France, 33000
        • Centre Rétine Gallien à Bordeaux
      • Brest, France, 29200
        • CHU Brest
      • Creteil, France, 94000
        • CHI Créteil
      • Lorient, France, 56100
        • CH SCORFF - Lorient
      • Lyon, France, 69004
        • Hôpital de la Croix Rousse
      • Marseille, France, 13385
        • Hôpital de la TIMONE
      • Marseille, France, 13008
        • Clinique Monticelli
      • Metz-Tessy, France, 74370
        • CHR Annecy
      • Nice, France, 06001
        • CHU Pasteur 2
      • Paris, France, 75014
        • Hopital Saint Joseph
      • Paris, France, 75019
        • Fondation Rothschild
      • Paris, France, 75475
        • Lariboisiere
      • Paris, France, 75012
        • Chno 1520
      • Paris, France, 75679
        • Cochin
      • Poissy, France, 78300
        • Hopital Poissy
      • Poitiers, France, 86021
        • Hôpital de La Milétrie Poitiers
      • Saint Germain En Laye, France, 78100
        • Hopital Saint Germain en Laye
      • Saint-Herblain, France, 44800
        • Centre OPHTA.Kervision
      • Strasbourg, France, 67000
        • Maison Rouge
      • Toulouse, France, 31059
        • CHU Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients treated with OZURDEX® in clinical practice.

Description

Inclusion Criteria:

-Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.

Exclusion Criteria:

-Patient not residing in metropolitan France.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
OZURDEX®
Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.
Drug: dexamethasone intravitreal implant
Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
Other Names:
  • OZURDEX®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
Time Frame: Baseline to Month 24
Baseline to Month 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to Achieve Maximum Gain in BCVA
Time Frame: 24 Months
24 Months
Change from Baseline in BCVA
Time Frame: Baseline, Week 6, Months 6, 12, 18 and 24
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
Time Frame: Baseline, Week 6, Month 6, 12, 18 and 24
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
Time Frame: Baseline, Week 6, Month 6, 12, 18 and 24
Baseline, Week 6, Month 6, 12, 18 and 24
Change from Baseline in Retinal Thickness
Time Frame: Baseline, Month 24
Baseline, Month 24
Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline
Time Frame: Baseline, Month 24
Baseline, Month 24
Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness
Time Frame: Month 24
Month 24
Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex®
Time Frame: Day 1
Day 1
Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Conditions when Placed on Treatment (Patient Characteristics, Glycosylated Hemoglobin (HbA1c) Level Control, Blood Pressure Control, Prior Treatments, Prior Treatment Failure)
Time Frame: Day 1
Day 1
Percentage of Participants Categorized by Conditions when Use of Ozurdex® (Number of Injections, Number of Follow-up Visits, Criteria for Retreatment and Discontinuation of Treatment)
Time Frame: 24 Months
24 Months
Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity
Time Frame: 24 Months
24 Months
Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg)
Time Frame: 24 Months
24 Months
Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline
Time Frame: 24 Months
24 Months
Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery
Time Frame: 24 Months
24 Months
Number of Participants with Incident Cataracts
Time Frame: 24 Months
24 Months
Number of Participants with Cataract Surgeries Related to Treatment or Injection
Time Frame: 24 Months
24 Months
Percentage of Participants with Serious Adverse Events
Time Frame: 24 Months
24 Months
Percentage of Participants with Death
Time Frame: 24 Months
24 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2017

Primary Completion (Actual)

December 19, 2018

Study Completion (Actual)

December 19, 2018

Study Registration Dates

First Submitted

December 22, 2016

First Submitted That Met QC Criteria

December 27, 2016

First Posted (Estimate)

December 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 14, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMA-EAME-EYE-0440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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