A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated

Phase 4

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Dexamethasone Intravitreal Implant

• Registration Number: NCT03953807
• Lead Sponsor: Allergan

Brief Summary

This study will evaluate the efficacy and safety of OZURDEX in patients with Diabetic Macular Edema when used in a real world setting in Spain and Portugal.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-13
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-09-05
• Primary Completion: 2022-07-04
• Study Completion: 2022-07-04
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• Prior diagnosis of diabetes mellitus (type 1 or type 2)
• Media clarity, pupillary dilation, and patient cooperation sufficient for all study procedures
• Written informed consent obtained in accordance with all local privacy requirements

Exclusion Criteria

• Uncontrolled systemic disease
• 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
• Patients who have been previously treated for DME (two focal laser allowed)
• Untreated diabetes or anticipated change (increase) of antidiabetic medications during the study
• Elevated IOP or glaucoma diagnosis
• Any active ocular infection or inflammation
• Aphakia
• A substantial cataract is present that is likely to be decreasing visual acuity by three lines or more (i.e., cataract would be reducing visual acuity to 20/40 or worse if the eye was otherwise normal)
• Anticipated need for ocular surgery during the study
• History of vitrectomy or incisional glaucoma surgery - Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception
• Known allergy, hypersensitivity or contraindication to the study medication, its components, or povidone iodine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ozurdex	Dexamethasone Intravitreal Implant	OZURDEX implant 700 μg

Primary Outcome Measures

Name	Time	Method
Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection	Baseline, at Month 10 through 12

Secondary Outcome Measures

Name	Time	Method
Time to 3rd injection	During the 12 to 14-month study
AUC for BCVA	Baseline, During the 12 to 14-month study
Mean number of injections administered	During the 12- to 14-month study
Mean retreatment interval in months	During the 12 to 14-month study
Area under the curve (AUC) for CRT	Baseline, During the 12 to 14-month study
Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)	Baseline, at Month 14	25 vision-targeted questions representing 11 vision-related constructs, plus an additional single-item general health rating question. All items are scored so that a high score represents better functioning. Original numeric values from the survey will be recoded with the worst and best possible scores set at 0 and 100 points, respectively. In this format, scores represent the achieved percentage of the total possible score, e.g. a score of 50 represents 50% of the highest possible score.
Proportion of patients with 2nd injection	During the 12 to 14-month study
Proportion of patients with 3rd injection	During the 12 to 14-month study
Time to 2nd injection	During the 12 to 14-month study
Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received	Baseline, at Month 10 through 12

Trial Locations

Locations (26)

Chuc /Id# 233643; 🇵🇹 Coimbra, Portugal

IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667; 🇵🇹 Lisbon, Portugal

Hospital de Santo Andre /ID# 233670; 🇵🇹 Leiria, Portugal

Centro Hospitalar de Lisboa Norte /ID# 233684; 🇵🇹 Lisbon, Portugal

Ulsam /Id# 233635; 🇵🇹 Viana do Castelo, Portugal

Hospital de Vila Franca de Xira /ID# 233682; 🇵🇹 Vila Franca de Xira, Portugal

Hospital Universitari Son Espases /ID# 233601; 🇪🇸 Palma de Mallorca, Illes Balears, Spain

Instituto Oftalmológico Gómez-Ulla /ID# 233590; 🇪🇸 Santiago de Compostela, A Coruna, Spain

ICOF Hospital Clinic De Barcelona /ID# 233675; 🇪🇸 Barcelona, Spain

Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597; 🇪🇸 Majadahonda, Madrid, Spain

Centro de Oftalmología Barraquer /ID# 233591; 🇪🇸 Barcelona, Spain

CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618; 🇪🇸 Pamplona, Navarra, Spain

Instituto de Microcirugía Ocular /ID# 233689; 🇪🇸 Barcelona, Spain

Hospital Universitario de Cruces /ID# 233673; 🇪🇸 Bilbao, Spain

Hospital Universitario Insular de Gran Canaria /ID# 233658; 🇪🇸 Les Palma, Spain

Hospital Universitario La Paz /ID# 233619; 🇪🇸 Madrid, Spain

Oftalvist Moncloa /ID# 233647; 🇪🇸 Madrid, Spain

Vissum Madrid /ID# 233646; 🇪🇸 Madrid, Spain

Hospital Clinico Universitario San Carlos /ID# 233578; 🇪🇸 Madrid, Spain

Hospital Universitario Virgen del Rocio /ID# 233609; 🇪🇸 Sevilla, Spain

Hospital Universitario y Politecnico La Fe /ID# 233613; 🇪🇸 Valencia, Spain

Hospital General Universitario de Valencia /ID# 233600; 🇪🇸 Valencia, Spain

Hospital Universitario Arnau Vilanova /ID# 233594; 🇪🇸 Valencia, Spain

Hospital Universitario de Araba /ID# 233693; 🇪🇸 Vitoria Gasteiz, Spain

Hospital Clinico Universitario Lozano Blesa /ID# 233685; 🇪🇸 Zaragoza, Spain

Miguel Servet University Hospital /ID# 233629; 🇪🇸 Zaragoza, Spain