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

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ClinicalTrials.gov Identifier: NCT03953807
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

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
Diabetic Macular Edema Drug: Dexamethasone Intravitreal Implant Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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
Estimated Study Start Date : May 27, 2019
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Ozurdex
OZURDEX implant 700 μg
Drug: Dexamethasone Intravitreal Implant
Implant 700 μg




Primary Outcome Measures :
  1. Mean change in best corrected visual acuity (BCVA) 2 months (± 2 weeks) after the last injection [ Time Frame: 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 [ Time Frame: Baseline, at Month 10 through 12 ]
  2. Mean retreatment interval in months [ Time Frame: During the 12 to 14-month study ]
  3. Area under the curve (AUC) for CRT [ Time Frame: Baseline, During the 12 to 14-month study ]
  4. AUC for BCVA [ Time Frame: Baseline, During the 12 to 14-month study ]
  5. Mean change in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) [ Time Frame: 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 [ Time Frame: During the 12 to 14-month study ]
  7. Proportion of patients with 3rd injection [ Time Frame: During the 12 to 14-month study ]
  8. Mean number of injections administered [ Time Frame: During the 12- to 14-month study ]
  9. Time to 3rd injection [ Time Frame: During the 12 to 14-month study ]
  10. Time to 2nd injection [ Time Frame: During the 12 to 14-month study ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953807


Contacts
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Contact: Clinical Trials Registry Team 877-277-8566 IR-CTRegistration@Allergan.com

Locations
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Portugal
CHUC - Centro Hospitalar e Universitário de Coimbra Not yet recruiting
Coimbra, Portugal, 3000-075
Contact: Study Coordinator    351 239 800 100      
Hospital de Vila Franca de Xira Not yet recruiting
Vila Franca de Xira, Portugal, 2600-009
Contact: Study Coordinator    351 263 006 500      
Spain
C/ Muntaner 314 Not yet recruiting
Barcelona, Spain, 8021
Contact: Study Coordinator    34 2095311      
Instituto Clínic de Oftalmología (ICOF) Not yet recruiting
Barcelona, Spain, 8028
Contact: Study Coordinator    34 9322755400      
Carrer Josep Maria Lladó, 3, 08035 Barcelona Not yet recruiting
Barcelona, Spain, 8035
Contact: Study Coordinator    934000700      
Hospital Universitari de Bellvitge Not yet recruiting
Barcelona, Spain, 8907
Contact: Study Coordinator    34932607705      
Hospital Universitario de Araba Not yet recruiting
Bilbao, Spain, 48013
Contact: Study Coordinator    34 619621634      
Instituto Oftalmológico Gomez Ulla Not yet recruiting
Coruna, Spain, 15706
Contact: Study Coordinator    34 661928147      
CIA nica La Luz Not yet recruiting
Madrid, Spain, 28003
Contact: Study Coordinator    34 913303001      
Av. de Valladolid, 81, 28008 Madrid Not yet recruiting
Madrid, Spain, 28008
Contact: Study Coordinator    34667730367      
Hospital Universitario La Paz Not yet recruiting
Madrid, Spain, 28046
Contact: Study Coordinator    34 917 27 70 00      
Hospital Universitario Puerta de Hierro Majadahonda FOUNDATION ADDRESS Not yet recruiting
Majadahonda, Spain, 28222
Contact: Study Coordinator    34610435999      
Clnica Universitaria de Navarra Not yet recruiting
Pamplona, Spain, 31009
Contact: Study Coordinator    34 948296331      
Hospital Virgen del Rocío Not yet recruiting
Seville, Spain, 41013
Contact: Study Coordinator    34691352224      
Hospital Arnau Vilanova Not yet recruiting
Valencia, Spain, 46015
Contact: Study Coordinator    34 619105103      
Hospital Clínico Universitario de Zaragoza Not yet recruiting
Zaragoza, Spain, 50009
Contact: Study Coordinator    34 976 76 57 00      
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Rachel Zaw Allergan

Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03953807     History of Changes
Other Study ID Numbers: CMO-MA-EYE-0603
2018-004785-33 ( EudraCT Number )
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action