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

Allergan115 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

115

Conditions

Diabetic Macular Edema

Interventions

dexamethasone intravitreal implantDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: -Patient with Diabetic Macular Edema (DME) treated with Ozurdex® in clinical practice. Exclusion Criteria: -Patient not residing in metropolitan France.

Locations (25)

Centre MGM

Aix-en-Provence, France

Ballanger

Aulnay-sous-Bois, France

Outcomes

Primary Outcomes

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

Time to Achieve Maximum Gain in BCVA

Time frame: 24 Months

Change from Baseline in BCVA

Time frame: 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

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

Change from Baseline in Retinal Thickness

Time frame: Baseline, Month 24

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

Time frame: 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

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

Time frame: Day 1

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

Créteil, France

CH SCORFF - Lorient

Lorient, France

Hopital De La Croix Rousse

Lyon, France

...and 15 more locations

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

Time frame: Day 1

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

Time frame: 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

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

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

Time frame: 24 Months

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

Time frame: 24 Months

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

Time frame: 24 Months

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

Time frame: 24 Months

Number of Participants with Incident Cataracts

Time frame: 24 Months

Number of Participants with Cataract Surgeries Related to Treatment or Injection

Time frame: 24 Months

Percentage of Participants with Serious Adverse Events

Time frame: 24 Months

Percentage of Participants with Death

Time frame: 24 Months