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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Dexamethasone Intravitreal Implant
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chuc /Id# 233643
  • Hospital de Santo Andre /ID# 233670
  • IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667
  • Centro Hospitalar de Lisboa Norte /ID# 233684
  • Ulsam /Id# 233635
  • Hospital de Vila Franca de Xira /ID# 233682
  • Instituto Oftalmológico Gómez-Ulla /ID# 233590
  • Hospital Universitari Son Espases /ID# 233601
  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597
  • CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618
  • Centro de Oftalmología Barraquer /ID# 233591
  • ICOF Hospital Clinic De Barcelona /ID# 233675
  • Instituto de Microcirugía Ocular /ID# 233689
  • Hospital Universitario de Cruces /ID# 233673
  • Hospital Universitario Insular de Gran Canaria /ID# 233658
  • Oftalvist Moncloa /ID# 233647
  • Vissum Madrid /ID# 233646
  • Hospital Clinico Universitario San Carlos /ID# 233578
  • Hospital Universitario La Paz /ID# 233619
  • Hospital Universitario Virgen del Rocio /ID# 233609
  • Hospital General Universitario de Valencia /ID# 233600
  • Hospital Universitario Arnau Vilanova /ID# 233594
  • Hospital Universitario y Politecnico La Fe /ID# 233613
  • Hospital Universitario de Araba /ID# 233693
  • Hospital Clinico Universitario Lozano Blesa /ID# 233685
  • Miguel Servet University Hospital /ID# 233629

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ozurdex

Arm Description

OZURDEX implant 700 μg

Outcomes

Primary Outcome Measures

Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection

Secondary Outcome Measures

Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received
Mean retreatment interval in months
Area under the curve (AUC) for CRT
AUC for BCVA
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.
Proportion of patients with 2nd injection
Proportion of patients with 3rd injection
Mean number of injections administered
Time to 3rd injection
Time to 2nd injection

Full Information

First Posted
May 13, 2019
Last Updated
October 5, 2022
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03953807
Brief Title
A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
Acronym
EYEberia
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
July 4, 2022 (Actual)
Study Completion Date
July 4, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ozurdex
Arm Type
Experimental
Arm Description
OZURDEX implant 700 μg
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Intravitreal Implant
Intervention Description
Implant 700 μg
Primary Outcome Measure Information:
Title
Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection
Time Frame
Baseline, at Month 10 through 12
Secondary Outcome Measure Information:
Title
Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received
Time Frame
Baseline, at Month 10 through 12
Title
Mean retreatment interval in months
Time Frame
During the 12 to 14-month study
Title
Area under the curve (AUC) for CRT
Time Frame
Baseline, During the 12 to 14-month study
Title
AUC for BCVA
Time Frame
Baseline, During the 12 to 14-month study
Title
Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)
Description
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.
Time Frame
Baseline, at Month 14
Title
Proportion of patients with 2nd injection
Time Frame
During the 12 to 14-month study
Title
Proportion of patients with 3rd injection
Time Frame
During the 12 to 14-month study
Title
Mean number of injections administered
Time Frame
During the 12- to 14-month study
Title
Time to 3rd injection
Time Frame
During the 12 to 14-month study
Title
Time to 2nd injection
Time Frame
During the 12 to 14-month study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Chuc /Id# 233643
City
Coimbra
ZIP/Postal Code
3004-561
Country
Portugal
Facility Name
Hospital de Santo Andre /ID# 233670
City
Leiria
ZIP/Postal Code
2410-197
Country
Portugal
Facility Name
IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667
City
Lisbon
ZIP/Postal Code
1150-085
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Norte /ID# 233684
City
Lisbon
ZIP/Postal Code
1649 028
Country
Portugal
Facility Name
Ulsam /Id# 233635
City
Viana do Castelo
ZIP/Postal Code
4904-495
Country
Portugal
Facility Name
Hospital de Vila Franca de Xira /ID# 233682
City
Vila Franca de Xira
ZIP/Postal Code
2600-009
Country
Portugal
Facility Name
Instituto Oftalmológico Gómez-Ulla /ID# 233590
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15706
Country
Spain
Facility Name
Hospital Universitari Son Espases /ID# 233601
City
Palma de Mallorca
State/Province
Illes Balears
ZIP/Postal Code
07120
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Centro de Oftalmología Barraquer /ID# 233591
City
Barcelona
ZIP/Postal Code
08021
Country
Spain
Facility Name
ICOF Hospital Clinic De Barcelona /ID# 233675
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Instituto de Microcirugía Ocular /ID# 233689
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario de Cruces /ID# 233673
City
Bilbao
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario Insular de Gran Canaria /ID# 233658
City
Les Palma
ZIP/Postal Code
35016
Country
Spain
Facility Name
Oftalvist Moncloa /ID# 233647
City
Madrid
ZIP/Postal Code
28008
Country
Spain
Facility Name
Vissum Madrid /ID# 233646
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
Hospital Clinico Universitario San Carlos /ID# 233578
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 233619
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio /ID# 233609
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hospital General Universitario de Valencia /ID# 233600
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Hospital Universitario Arnau Vilanova /ID# 233594
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 233613
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Universitario de Araba /ID# 233693
City
Vitoria Gasteiz
ZIP/Postal Code
01004
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa /ID# 233685
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Miguel Servet University Hospital /ID# 233629
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.AllerganClinicalTrials.com
Description
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

Learn more about this trial

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

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