Study to Evaluate the Efficacy and Safety of OZURDEX® in Treatment Naïve Patients with Diabetic Macular Edema

Phase 1

• Conditions: Diabetic Macular Edema; MedDRA version: 20.1 Level: LLT Classification code 10057934 Term: Diabetic macular edema System Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2018-004785-33-ES
• Lead Sponsor: Allergan Pharmaceuticals International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-11
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified