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Completed

NCT Number: NCT03953807

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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Chuc /Id# 233643, Coimbra, Portugal

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

Implant 700 μg

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Official study 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

Acronym: EYEberia

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 17, 2019
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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