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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Creteil
      • Lorient, France, 56100
        • CH SCORFF - Lorient
      • Lyon, France, 69004
        • Hopital 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
        • Lariboisière
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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