A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
NCT ID: NCT03953807
Last Updated: 2022-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
82 participants
INTERVENTIONAL
2019-09-05
2022-07-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ozurdex
OZURDEX implant 700 μg
Dexamethasone Intravitreal Implant
Implant 700 μg
Interventions
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Dexamethasone Intravitreal Implant
Implant 700 μg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Chuc /Id# 233643
Coimbra, , Portugal
Hospital de Santo Andre /ID# 233670
Leiria, , Portugal
IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667
Lisbon, , 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
Instituto Oftalmológico Gómez-Ulla /ID# 233590
Santiago de Compostela, A Coruna, Spain
Hospital Universitari Son Espases /ID# 233601
Palma de Mallorca, Balearic Islands, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597
Majadahonda, Madrid, Spain
CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618
Pamplona, Navarre, Spain
Centro de Oftalmología Barraquer /ID# 233591
Barcelona, , Spain
ICOF Hospital Clinic De Barcelona /ID# 233675
Barcelona, , 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
Oftalvist Moncloa /ID# 233647
Madrid, , Spain
Vissum Madrid /ID# 233646
Madrid, , Spain
Hospital Clinico Universitario San Carlos /ID# 233578
Madrid, , Spain
Hospital Universitario La Paz /ID# 233619
Madrid, , Spain
Hospital Universitario Virgen del Rocio /ID# 233609
Seville, , Spain
Hospital General Universitario de Valencia /ID# 233600
Valencia, , Spain
Hospital Universitario Arnau Vilanova /ID# 233594
Valencia, , Spain
Hospital Universitario y Politecnico La Fe /ID# 233613
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
Countries
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Related Links
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Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact [email protected] for assistance.,To be considered as a site for current and futur
Other Identifiers
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2018-004785-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CMO-MA-EYE-0603
Identifier Type: -
Identifier Source: org_study_id
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