Clinical trial NCT03003416: Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)
Official title: Efficacy of Ozurdex® in the Treatment of Diabetic Macular Edema (DME)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with OZURDEX® in clinical practice.

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).


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-Patient not residing in metropolitan France.

Primary outcomes:
measure: Best Gain in Best Corrected Visual Acuity (BCVA) compared to Baseline Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale
timeFrame: Baseline to Month 24
Secondary outcomes:
measure: Time to Achieve Maximum Gain in BCVA
timeFrame: 24 Months
measure: Change from Baseline in BCVA
timeFrame: Baseline, Week 6, Months 6, 12, 18 and 24
measure: Percentage of Participants with a Gain (Improvement) in BCVA of at Least 10 Letters from Baseline
timeFrame: Baseline, Week 6, Month 6, 12, 18 and 24
measure: Percentage of Participants with a Gain (Improvement) in BCVA of at Least 15 Letters from Baseline
timeFrame: Baseline, Week 6, Month 6, 12, 18 and 24
measure: Change from Baseline in Retinal Thickness
timeFrame: Baseline, Month 24
measure: Percentage of Participants with a 20% Reduction in Retinal Thickness compared to Baseline
timeFrame: Baseline, Month 24
measure: Percentage of Participants with Disappearance of DME defined by Disappearance of Cyst or Obtaining a Normal Retinal Thickness
timeFrame: Month 24
measure: Percentage of Participants Categorized by Demographic Characteristics Treated or Not Treated with Ozurdex®
timeFrame: Day 1
measure: Percentage of Physicians Categorized by Age, Sex, Type of Practice, Number of Yearly Injections
timeFrame: Day 1
measure: Percentage of Participants Categorized by Characteristics of Disease (DME or Diabetes)
timeFrame: Day 1
measure: Percentage of Participants Categorized by Treatment Methods at Inclusion (Therapeutic Decision for inclusion or Reason for Non-Treatment)
timeFrame: Day 1
measure: 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)
timeFrame: Day 1
measure: 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)
timeFrame: 24 Months
measure: Percentage of Participants with at Least 1 Adverse Event (AE) based on intensity, relationship with the treatment and severity
timeFrame: 24 Months
measure: Percentage of Participants by Intra-ocular Pressure (IOP) Categories (≥25 and ≥35 mmHg)
timeFrame: 24 Months
measure: Number of Participants with Intra-ocular Pressure (IOP) Changes >10 mmHg from Baseline
timeFrame: 24 Months
measure: Percentage of Participants Treated with a Hypotonic Agent, Laser, Filtration Surgery
timeFrame: 24 Months
measure: Number of Participants with Incident Cataracts
timeFrame: 24 Months
measure: Number of Participants with Cataract Surgeries Related to Treatment or Injection
timeFrame: 24 Months
measure: Percentage of Participants with Serious Adverse Events
timeFrame: 24 Months
measure: Percentage of Participants with Death
timeFrame: 24 Months
Other outcomes:
Locations:
city: Aix-En-Provence
country: France
facility: Centre MGM
city: Aulnay-Sous-Bois
country: France
facility: Ballanger
city: Blois
country: France
facility: CH BLOIS
city: Bobigny
country: France
facility: CH Avicennes Bobigny
city: Bordeaux
country: France
facility: Centre Rétine Gallien à Bordeaux
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: CHU Brest
city: Creteil
country: France
facility: CHI Créteil
city: Lorient
country: France
facility: CH SCORFF - Lorient
city: Lyon
country: France
facility: Hopital De La Croix Rousse
city: Marseille
country: France
facility: Clinique Monticelli
city: Marseille
country: France
facility: Hopital de la Timone
city: Metz-Tessy
country: France
facility: CHR Annecy
city: Nice
country: France
facility: CHU Pasteur 2
city: Paris
country: France
facility: Chno 1520
city: Paris
country: France
facility: Hopital Saint Joseph
city: Paris
country: France
facility: Fondation Rothschild
city: Paris
country: France
facility: Lariboisiere
city: Paris
country: France
facility: COCHIN
city: Poissy
country: France
facility: Hopital Poissy
city: Poitiers
country: France
facility: Hôpital de La Milétrie Poitiers
city: Saint Germain En Laye
country: France
facility: Hopital Saint Germain en Laye
city: Saint-Herblain
country: France
facility: Centre OPHTA.Kervision
city: Strasbourg
country: France
facility: Maison Rouge
city: Toulouse
country: France
facility: Chu Toulouse
Study officials:
affiliation: Allergan
name: Nathalie Mesnard
role: STUDY_DIRECTOR
References: