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Completed

NCT Number: NCT03003416

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

This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre MGM, Aix-en-Provence, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-Patient not residing in metropolitan France.

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.

Other names: OZURDEX®

Primary outcomes

  1. 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

Secondary outcomes

  1. Time to Achieve Maximum Gain in BCVA

    Time frame: 24 Months

  2. Change from Baseline in BCVA

    Time frame: Baseline, Week 6, Months 6, 12, 18 and 24

  3. 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

  4. 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

  5. Change from Baseline in Retinal Thickness

    Time frame: Baseline, Month 24

  6. Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline

    Time frame: Baseline, Month 24

  7. Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness

    Time frame: Month 24

  8. Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex®

    Time frame: Day 1

  9. Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections

    Time frame: Day 1

  10. Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes)

    Time frame: Day 1

  11. Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment)

    Time frame: Day 1

  12. 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

  13. 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

  14. Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity

    Time frame: 24 Months

  15. Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg)

    Time frame: 24 Months

  16. Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline

    Time frame: 24 Months

  17. Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery

    Time frame: 24 Months

  18. Number of Participants with Incident Cataracts

    Time frame: 24 Months

  19. Number of Participants with Cataract Surgeries Related to Treatment or Injection

    Time frame: 24 Months

  20. Percentage of Participants with Serious Adverse Events

    Time frame: 24 Months

  21. Percentage of Participants with Death

    Time frame: 24 Months

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Acronym: Louvre 3

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2016
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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