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

A 12-month, Prospective, Open-label, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® (Dexamethasone Intravitreal Implant) in Treatment Naïve Patients (According to Standard Clinical Practice) With Diabetic Macular Edema

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Dexamethasone Intravitreal Implant

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 4

Contacts and Locations

Study Locations

• Portugal
  • Coimbra, Portugal, 3004-561
    • Chuc /Id# 233643
  • Leiria, Portugal, 2410-197
    • Hospital de Santo Andre /ID# 233670
  • Lisbon, Portugal, 1150-085
    • IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667
  • Lisbon, Portugal, 1649 028
    • Centro Hospitalar de Lisboa Norte /ID# 233684
  • Viana do Castelo, Portugal, 4904-495
    • Ulsam /Id# 233635
  • Vila Franca de Xira, Portugal, 2600-009
    • Hospital de Vila Franca de Xira /ID# 233682
• Spain
  • Barcelona, Spain, 08021
    • Centro de Oftalmología Barraquer /ID# 233591
  • Barcelona, Spain, 08028
    • ICOF Hospital Clinic De Barcelona /ID# 233675
  • Barcelona, Spain, 08035
    • Instituto de Microcirugía Ocular /ID# 233689
  • Bilbao, Spain, 48903
    • Hospital Universitario de Cruces /ID# 233673
  • Les Palma, Spain, 35016
    • Hospital Universitario Insular de Gran Canaria /ID# 233658
  • Madrid, Spain, 28008
    • Oftalvist Moncloa /ID# 233647
  • Madrid, Spain, 28035
    • Vissum Madrid /ID# 233646
  • Madrid, Spain, 28040
    • Hospital Clinico Universitario San Carlos /ID# 233578
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz /ID# 233619
  • Sevilla, Spain, 41013
    • Hospital Universitario Virgen del Rocio /ID# 233609
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia /ID# 233600
  • Valencia, Spain, 46015
    • Hospital Universitario Arnau Vilanova /ID# 233594
  • Valencia, Spain, 46026
    • Hospital Universitario y Politecnico La Fe /ID# 233613
  • Vitoria Gasteiz, Spain, 01004
    • Hospital Universitario de Araba /ID# 233693
  • Zaragoza, Spain, 50009
    • Hospital Clinico Universitario Lozano Blesa /ID# 233685
  • Zaragoza, Spain, 50009
    • Miguel Servet University Hospital /ID# 233629
  • A Coruna
    • Santiago de Compostela, A Coruna, Spain, 15706
      • Instituto Oftalmológico Gómez-Ulla /ID# 233590
  • Illes Balears
    • Palma de Mallorca, Illes Balears, Spain, 07120
      • Hospital Universitari Son Espases /ID# 233601
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ozurdex; OZURDEX implant 700 μg	Drug: Dexamethasone Intravitreal Implant; Implant 700 μg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received		Baseline, at Month 10 through 12
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
AUC for BCVA		Baseline, During the 12 to 14-month study
Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)	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.	Baseline, at Month 14
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
Mean number of injections administered		During the 12- to 14-month study
Time to 3rd injection		During the 12 to 14-month study
Time to 2nd injection		During the 12 to 14-month study

Collaborators and Investigators

• Sponsor: Allergan

Publications and helpful links

Helpful Links

• Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.,To be considered as a site for current and futur

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Actual): July 4, 2022
• Study Completion (Actual): July 4, 2022

Study Registration Dates

• First Submitted: May 13, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: CMO-MA-EYE-0603; 2018-004785-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No