Clinical trial NCT03953807: A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2019-05-17
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection
timeFrame: Baseline, at Month 10 through 12
Secondary outcomes:
measure: Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received
timeFrame: Baseline, at Month 10 through 12
measure: Mean retreatment interval in months
timeFrame: During the 12 to 14-month study
measure: Area under the curve (AUC) for CRT
timeFrame: Baseline, During the 12 to 14-month study
measure: AUC for BCVA
timeFrame: Baseline, During the 12 to 14-month study
measure: Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25)
timeFrame: Baseline, at Month 14
measure: Proportion of patients with 2nd injection
timeFrame: During the 12 to 14-month study
measure: Proportion of patients with 3rd injection
timeFrame: During the 12 to 14-month study
measure: Mean number of injections administered
timeFrame: During the 12- to 14-month study
measure: Time to 3rd injection
timeFrame: During the 12 to 14-month study
measure: Time to 2nd injection
timeFrame: During the 12 to 14-month study
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: Chuc /Id# 233643
city: Leiria
country: Portugal
facility: Hospital de Santo Andre /ID# 233670
city: Lisbon
country: Portugal
facility: IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667
city: Lisbon
country: Portugal
facility: Centro Hospitalar de Lisboa Norte /ID# 233684
city: Viana do Castelo
country: Portugal
facility: Ulsam /Id# 233635
city: Vila Franca de Xira
country: Portugal
facility: Hospital de Vila Franca de Xira /ID# 233682
city: Santiago de Compostela
country: Spain
facility: Instituto Oftalmológico Gómez-Ulla /ID# 233590
state: A Coruna
city: Palma de Mallorca
country: Spain
facility: Hospital Universitari Son Espases /ID# 233601
state: Illes Balears
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597
state: Madrid
city: Pamplona
country: Spain
facility: CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618
state: Navarra
city: Barcelona
country: Spain
facility: Centro de Oftalmología Barraquer /ID# 233591
city: Barcelona
country: Spain
facility: ICOF Hospital Clinic De Barcelona /ID# 233675
city: Barcelona
country: Spain
facility: Instituto de Microcirugía Ocular /ID# 233689
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces /ID# 233673
city: Les Palma
country: Spain
facility: Hospital Universitario Insular de Gran Canaria /ID# 233658
city: Madrid
country: Spain
facility: Oftalvist Moncloa /ID# 233647
city: Madrid
country: Spain
facility: Vissum Madrid /ID# 233646
city: Madrid
country: Spain
facility: Hospital Clinico Universitario San Carlos /ID# 233578
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 233619
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio /ID# 233609
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia /ID# 233600
city: Valencia
country: Spain
facility: Hospital Universitario Arnau Vilanova /ID# 233594
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 233613
city: Vitoria Gasteiz
country: Spain
facility: Hospital Universitario de Araba /ID# 233693
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa /ID# 233685
city: Zaragoza
country: Spain
facility: Miguel Servet University Hospital /ID# 233629
Study officials:
affiliation: Allergan
name: ALLERGAN INC.
role: STUDY_DIRECTOR
References: