Diabetic Macular Edema MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853
Conditions
Interventions
Trade Name: OZURDEX®
Product Name: OZURDEX®
Pharmaceutical Form: Intravitreal implant in applicator
INN or Proposed INN: DEXAMETHASONE
O
Sponsors
Allergan Pharmaceuticals International Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female = 18 years of age 2. Prior diagnosis of diabetes mellitus (type 1 or type 2) 3. Presence of macular edema associated with diabetic retinopathy defined as macular thickening by optical coherence tomography (OCT) assessed by the investigator with the following characteristics: 3.1. Involving the center of the macula (fovea) 3.2. Visual acuity (VA) decrease attributable to macular edema 4. Patients who are treatment naïve prior to enrollment in this study but have been prescribed OZURDEX by a physician. The prescribing information is at the discretion of the physician and reflects their standard of practice 5. BCVA score between 20 and 70 letters (approximately 20/40 to 20/400 on the Snellen scale) using the Early Treatment Diabetic Retinopathy Study (ETDRS) method at the Baseline visit 6. Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures 7. Women of childbearing potential should have a negative urine pregnancy test at the Baseline visit 8. Written informed consent obtained in accordance with all local privacy requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: Investigators must refer to the Summary of Product Characteristics (SPC) for information on contraindications (Section 4.3), Warnings (Section 4.4), and Pregnancy and Lactation (Section 4.6). 1. Uncontrolled systemic disease 2. History of disease, metabolic dysfunction, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of the investigational drug, might affect the interpretation of study results, or render the patient at high risk from treatment complications 3. Patients who have been previously treated for DME (use of two focal laser allowed) 4. Presence of vitreomacular traction or pathology of epiretinal membrane that, in the opinion of the investigator, may significantly interfere with functional response to treatment 5. Presence of anatomic biomarkers in OCT (disorganization of the retinal inner layers, damage of the ellipsoid zone) and OCT angiography (macular ischemia) that, in the opinion of the investigator, may significantly interfere with functional response to treatment 6. Use of systemic corticosteroids within 1 month prior to Screening 7. Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study 8. Elevated IOP or glaucoma diagnosis 9. A substantial cataract is present that in the opinion of the investigator will need cataract surgery during the study and/or will not allow to perform imaging tests. ( If the patients is pseudophakic, cataract surgery was performed at least 3 months before recruitment in this study. 10. Anticipated need for ocular surgery during the study 11. History of vitrectomy or incisional glaucoma surgery 12. Use of any intravenous steroid or intravitreal triamcinolone prior to Screening 13. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception 14. Any condition that, in the opinion of the investigator, may interfere with follow up visits 15. Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to evaluate the efficacy and safety of OZURDEX in patients with DME when used in a real world setting in Spain and Portugal.;Secondary Objective: Not applicable;Primary end point(s): Mean change in BCVA 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline;Timepoint(s) of evaluation of this end point: Mean change in best-corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Mean change from Baseline in CRT 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline • Mean retreatment interval • Mean number of injections administered during the 12- to 14-month study • AUC for CRT • AUC for BCVA • Mean change from Baseline in the NEI VFQ-25 at the Final Visit • Proportion of patients with 2nd injection during the study • Proportion of patients with 3rd injection during the study • Time to 2nd injection/time to 3rd injection Safety endpoints measured in this study include: • Nature, severity, and frequency of adverse events • Change in IOP • Cataract progression or development • Cardiovascular events during the treatment period ; Timepoint(s) of evaluation of this end point: • Mean change from Baseline in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received at Month 10 through 12 compared to Baseline • Mean retreatment interval • Mean number of injections administered during the 12- to 14-month study • Area under the curve (AUC) for CRT • AUC for BCVA • Mean change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire (VFQ)-25 at the Final Visit • Proportion of patients with 2nd injection during the study • Proportion of patients with 3rd injection during the study • Time to 2nd injection/time to 3rd injection | — |
Countries
Spain
Contacts
Public ContactRachel Zaw
Allergan Pharmaceuticals International Limited
Outcome results
None listed