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

NCT03953807 | Completed Phase 4

• 2 other identifiers: CMO-MA-EYE-06032018-004785-33
• Study Type: interventional
• Target: 82
• Locations: 2 countries
• Sites: 26

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.

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

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

  Baseline, at Month 10 through 12

Secondary Outcomes (10)

• 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)

  Baseline, at Month 14

Study Arms (1)

Ozurdex

EXPERIMENTAL

OZURDEX implant 700 μg

Drug: Dexamethasone Intravitreal Implant

Interventions

Dexamethasone Intravitreal Implant DRUG

Implant 700 μg

Ozurdex

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (26)

Chuc /Id# 233643

Coimbra, 3004-561, Portugal

Location

Hospital de Santo Andre /ID# 233670

Leiria, 2410-197, Portugal

Location

IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667

Lisbon, 1150-085, Portugal

Location

Centro Hospitalar de Lisboa Norte /ID# 233684

Lisbon, 1649 028, Portugal

Location

Ulsam /Id# 233635

Viana do Castelo, 4904-495, Portugal

Location

Hospital de Vila Franca de Xira /ID# 233682

Vila Franca de Xira, 2600-009, Portugal

Location

Instituto Oftalmológico Gómez-Ulla /ID# 233590

Santiago de Compostela, A Coruna, 15706, Spain

Location

Hospital Universitari Son Espases /ID# 233601

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597

Majadahonda, Madrid, 28222, Spain

Location

CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618

Pamplona, Navarre, 31008, Spain

Location

Centro de Oftalmología Barraquer /ID# 233591

Barcelona, 08021, Spain

Location

ICOF Hospital Clinic De Barcelona /ID# 233675

Barcelona, 08028, Spain

Location

Instituto de Microcirugía Ocular /ID# 233689

Barcelona, 08035, Spain

Location

Hospital Universitario de Cruces /ID# 233673

Bilbao, 48903, Spain

Location

Hospital Universitario Insular de Gran Canaria /ID# 233658

Les Palma, 35016, Spain

Location

Oftalvist Moncloa /ID# 233647

Madrid, 28008, Spain

Location

Vissum Madrid /ID# 233646

Madrid, 28035, Spain

Location

Hospital Clinico Universitario San Carlos /ID# 233578

Madrid, 28040, Spain

Location

Hospital Universitario La Paz /ID# 233619

Madrid, 28046, Spain

Location

Hospital Universitario Virgen del Rocio /ID# 233609

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia /ID# 233600

Valencia, 46014, Spain

Location

Hospital Universitario Arnau Vilanova /ID# 233594

Valencia, 46015, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 233613

Valencia, 46026, Spain

Location

Hospital Universitario de Araba /ID# 233693

Vitoria-Gasteiz, 01004, Spain

Location

Hospital Clinico Universitario Lozano Blesa /ID# 233685

Zaragoza, 50009, Spain

Location

Miguel Servet University Hospital /ID# 233629

Zaragoza, 50009, Spain

Location

Related 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

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 17, 2019
• Study Start: September 5, 2019
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• 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/

Locations

ES (20); PT (6)