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Diabetic Macular EdemaLouvre 3NCT03003416

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

An observational study of Diabetic Macular Edema, run by Allergan at 25 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
dexamethasone intravitreal implant
How many people
115 participants
Where
25 sitesFrance
Study dates
19 Oct 2017to 19 Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients treated with OZURDEX® in clinical practice.

Who may be able to join

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

Who cannot join

  • -Patient not residing in metropolitan France.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

France25 sites

  • Centre MGM

    Aix-en-Provence, 13090

  • Ballanger

    Aulnay-sous-Bois, 93600

  • CH BLOIS

    Blois, 41016

  • CH Avicennes Bobigny

    Bobigny, 93000

  • Centre Rétine Gallien à Bordeaux

    Bordeaux, 33000

  • CHU Bordeaux

    Bordeaux, 33000

  • CHU Brest

    Brest, 29200

  • CHI Créteil

    Créteil, 94000

  • CH SCORFF - Lorient

    Lorient, 56100

  • Hopital De La Croix Rousse

    Lyon, 69004

  • Clinique Monticelli

    Marseille, 13008

  • Hopital de la Timone

    Marseille, 13385

  • CHR Annecy

    Metz-Tessy, 74370

  • CHU Pasteur 2

    Nice, 06001

  • Chno 1520

    Paris, 75012

  • Hopital Saint Joseph

    Paris, 75014

  • Fondation Rothschild

    Paris, 75019

  • Lariboisiere

    Paris, 75475

  • COCHIN

    Paris, 75679

  • Hopital Poissy

    Poissy, 78300

  • Hôpital de La Milétrie Poitiers

    Poitiers, 86021

  • Hopital Saint Germain en Laye

    Saint-Germain-en-Laye, 78100

  • Centre OPHTA.Kervision

    Saint-Herblain, 44800

  • Maison Rouge

    Strasbourg, 67000

  • Chu Toulouse

    Toulouse, 31059

Other trials in France

About this study

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

Being tested
dexamethasone intravitreal implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexamethasone intravitreal implantDrug

    Also called OZURDEX®

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

Study groups in NCT03003416
Study groupRoleWhat they receive
OZURDEX®Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.
Receives: Drug: dexamethasone intravitreal implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale

    Measured: Baseline to Month 24

Secondary outcomes (21)

  1. Time to Achieve Maximum Gain in BCVA

    Measured: 24 Months

  2. Change from Baseline in BCVA

    Measured: 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

    Measured: 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

    Measured: Baseline, Week 6, Month 6, 12, 18 and 24

  5. Change from Baseline in Retinal Thickness

    Measured: Baseline, Month 24

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

    Measured: Baseline, Month 24

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

    Measured: Month 24

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

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: Day 1

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

    Measured: 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)

    Measured: 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)

    Measured: 24 Months

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

    Measured: 24 Months

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

    Measured: 24 Months

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

    Measured: 24 Months

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

    Measured: 24 Months

  18. Number of Participants with Incident Cataracts

    Measured: 24 Months

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

    Measured: 24 Months

  20. Percentage of Participants with Serious Adverse Events

    Measured: 24 Months

  21. Percentage of Participants with Death

    Measured: 24 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2016 (estimated)
  2. Study start19 Oct 2017
  3. Primary completion19 Dec 2018
  4. Study completion19 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
115 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03003416
Sponsor's protocol ID
GMA-EAME-EYE-0440
Acronym
Louvre 3
Status last verified
Mar 2019
First submitted
22 Dec 2016
Last updated
14 Mar 2019
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 36967448

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetic Macular Edema, run by Allergan at 25 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03003416, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2019.

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