Diabetic Macular Edema Clinical Trial
— Louvre 3Official title:
Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)
| Verified date | March 2019 |
| Source | Allergan |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).
| Status | Completed |
| Enrollment | 115 |
| Est. completion date | December 19, 2018 |
| Est. primary completion date | December 19, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: -Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice. Exclusion Criteria: -Patient not residing in metropolitan France. |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre MGM | Aix-En-Provence | |
| France | Ballanger | Aulnay-Sous-Bois | |
| France | CH BLOIS | Blois | |
| France | CH Avicennes Bobigny | Bobigny | |
| France | Centre Rétine Gallien à Bordeaux | Bordeaux | |
| France | CHU Bordeaux | Bordeaux | |
| France | CHU Brest | Brest | |
| France | CHI Créteil | Creteil | |
| France | CH SCORFF - Lorient | Lorient | |
| France | Hopital De La Croix Rousse | Lyon | |
| France | Clinique Monticelli | Marseille | |
| France | Hopital de la Timone | Marseille | |
| France | CHR Annecy | Metz-Tessy | |
| France | CHU Pasteur 2 | Nice | |
| France | Chno 1520 | Paris | |
| France | COCHIN | Paris | |
| France | Fondation Rothschild | Paris | |
| France | Hopital Saint Joseph | Paris | |
| France | Lariboisiere | Paris | |
| France | Hopital Poissy | Poissy | |
| France | Hôpital de La Milétrie Poitiers | Poitiers | |
| France | Hopital Saint Germain en Laye | Saint Germain En Laye | |
| France | Centre OPHTA.Kervision | Saint-Herblain | |
| France | Maison Rouge | Strasbourg | |
| France | Chu Toulouse | Toulouse |
| Lead Sponsor | Collaborator |
|---|---|
| Allergan |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Time to Achieve Maximum Gain in BCVA | 24 Months | ||
| Secondary | Change from Baseline in BCVA | Baseline, Week 6, Months 6, 12, 18 and 24 | ||
| Secondary | 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 | ||
| Secondary | 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 | ||
| Secondary | Change from Baseline in Retinal Thickness | Baseline, Month 24 | ||
| Secondary | Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline | Baseline, Month 24 | ||
| Secondary | Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness | Month 24 | ||
| Secondary | Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex® | Day 1 | ||
| Secondary | Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections | Day 1 | ||
| Secondary | Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes) | Day 1 | ||
| Secondary | Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment) | Day 1 | ||
| Secondary | 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) | Day 1 | ||
| Secondary | 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) | 24 Months | ||
| Secondary | Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity | 24 Months | ||
| Secondary | Percentage of Participants by Intra-ocular Pressure (IOP) Categories (=25 and =35 mmHg) | 24 Months | ||
| Secondary | Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline | 24 Months | ||
| Secondary | Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery | 24 Months | ||
| Secondary | Number of Participants with Incident Cataracts | 24 Months | ||
| Secondary | Number of Participants with Cataract Surgeries Related to Treatment or Injection | 24 Months | ||
| Secondary | Percentage of Participants with Serious Adverse Events | 24 Months | ||
| Secondary | Percentage of Participants with Death | 24 Months |
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