Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)
- Registration Number
- NCT03003416
- Lead Sponsor
- Allergan
- Brief Summary
This study will evaluate the efficacy of Ozurdex® as prescribed in clinical practice in France for the treatment of Diabetic Macular Edema (DME).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
-Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice.
-Patient not residing in metropolitan France.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OZURDEX® dexamethasone intravitreal implant Patients prescribed dexamethasone intravitreal implant (OZURDEX®) in clinical practice for the treatment of Diabetic Macular Edema.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of Participants with Cataract Surgeries Related to Treatment or Injection 24 Months 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 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 Change from Baseline in BCVA Baseline, Week 6, Months 6, 12, 18 and 24 Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes) Day 1 Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment) Day 1 Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg) 24 Months Percentage of Participants with Serious Adverse Events 24 Months Time to Achieve Maximum Gain in BCVA 24 Months 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 Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity 24 Months Change from Baseline in Retinal Thickness Baseline, Month 24 Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline Baseline, Month 24 Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness Month 24 Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex® Day 1 Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline 24 Months Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery 24 Months Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections 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) Day 1 Number of Participants with Incident Cataracts 24 Months Percentage of Participants with Death 24 Months
Trial Locations
- Locations (25)
CHU Brest
🇫🇷Brest, France
CHU Pasteur 2
🇫🇷Nice, France
CHU Bordeaux
🇫🇷Bordeaux, France
Hôpital de La Milétrie Poitiers
🇫🇷Poitiers, France
Hopital Saint Joseph
🇫🇷Paris, France
CH SCORFF - Lorient
🇫🇷Lorient, France
CH Avicennes Bobigny
🇫🇷Bobigny, France
Centre Rétine Gallien à Bordeaux
🇫🇷Bordeaux, France
Maison Rouge
🇫🇷Strasbourg, France
Centre MGM
🇫🇷Aix-En-Provence, France
Ballanger
🇫🇷Aulnay-Sous-Bois, France
CH BLOIS
🇫🇷Blois, France
CHI Créteil
🇫🇷Creteil, France
Hopital De La Croix Rousse
🇫🇷Lyon, France
Clinique Monticelli
🇫🇷Marseille, France
Hopital de la Timone
🇫🇷Marseille, France
CHR Annecy
🇫🇷Metz-Tessy, France
Chno 1520
🇫🇷Paris, France
Fondation Rothschild
🇫🇷Paris, France
Lariboisiere
🇫🇷Paris, France
COCHIN
🇫🇷Paris, France
Hopital Poissy
🇫🇷Poissy, France
Hopital Saint Germain en Laye
🇫🇷Saint Germain En Laye, France
Centre OPHTA.Kervision
🇫🇷Saint-Herblain, France
Chu Toulouse
🇫🇷Toulouse, France