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

Sponsor
Allergan (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03953807
Collaborator
(none)
150
Enrollment
26
Locations
1
Arm
35.8
Anticipated Duration (Months)
5.8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Intravitreal Implant
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 5, 2019
Anticipated Primary Completion Date :
Aug 30, 2022
Anticipated Study Completion Date :
Aug 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ozurdex

OZURDEX implant 700 μg

Drug: Dexamethasone Intravitreal Implant
Implant 700 μg

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received [Baseline, at Month 10 through 12]

  2. Mean retreatment interval in months [During the 12 to 14-month study]

  3. Area under the curve (AUC) for CRT [Baseline, During the 12 to 14-month study]

  4. AUC for BCVA [Baseline, During the 12 to 14-month study]

  5. 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.

  6. Proportion of patients with 2nd injection [During the 12 to 14-month study]

  7. Proportion of patients with 3rd injection [During the 12 to 14-month study]

  8. Mean number of injections administered [During the 12- to 14-month study]

  9. Time to 3rd injection [During the 12 to 14-month study]

  10. Time to 2nd injection [During the 12 to 14-month study]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

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

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT03953807
Other Study ID Numbers:
  • CMO-MA-EYE-0603
  • 2018-004785-33
First Posted:
May 17, 2019
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:
Macular Edema
Edema
Dexamethasone

Study Results

No Results Posted as of Jul 8, 2022