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

Diabetic Macular Edema Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953807
• Other study ID #: CMO-MA-EYE-0603
• Secondary ID: 2018-004785-33
• Status: Completed
• Phase: Phase 4
• Start date: September 5, 2019
• Est. completion date: July 4, 2022

Study information

• Verified date: October 2022
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 4, 2022
• Est. primary completion date: July 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone Intravitreal Implant
Implant 700 µg

Locations

Country	Name	City	State
Portugal	Chuc /Id# 233643	Coimbra
Portugal	Hospital de Santo Andre /ID# 233670	Leiria
Portugal	Centro Hospitalar de Lisboa Norte /ID# 233684	Lisbon
Portugal	IRL - Instituto de Retina e Diabetes Ocular de Lisboa /ID# 233667	Lisbon
Portugal	Ulsam /Id# 233635	Viana do Castelo
Portugal	Hospital de Vila Franca de Xira /ID# 233682	Vila Franca de Xira
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	Hospital Clinico Universitario San Carlos /ID# 233578	Madrid
Spain	Hospital Universitario La Paz /ID# 233619	Madrid
Spain	Oftalvist Moncloa /ID# 233647	Madrid
Spain	Vissum Madrid /ID# 233646	Madrid
Spain	Hospital Universitario Puerta de Hierro, Majadahonda /ID# 233597	Majadahonda	Madrid
Spain	Hospital Universitari Son Espases /ID# 233601	Palma de Mallorca	Illes Balears
Spain	CLINICA UNIVERSIDAD DE NAVARRA-Pamplona /ID# 233618	Pamplona	Navarra
Spain	Instituto Oftalmológico Gómez-Ulla /ID# 233590	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen del Rocio /ID# 233609	Sevilla
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

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

Portugal,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection		Baseline, at Month 10 through 12
Secondary	Mean change in Central Retinal Thickness (CRT) 2 months (± 2 weeks) after the last injection received		Baseline, at Month 10 through 12
Secondary	Mean retreatment interval in months		During the 12 to 14-month study
Secondary	Area under the curve (AUC) for CRT		Baseline, During the 12 to 14-month study
Secondary	AUC for BCVA		Baseline, During the 12 to 14-month study
Secondary	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.	Baseline, at Month 14
Secondary	Proportion of patients with 2nd injection		During the 12 to 14-month study
Secondary	Proportion of patients with 3rd injection		During the 12 to 14-month study
Secondary	Mean number of injections administered		During the 12- to 14-month study
Secondary	Time to 3rd injection		During the 12 to 14-month study
Secondary	Time to 2nd injection		During the 12 to 14-month study

External 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