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Completed

NCT Number: NCT02188173

An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)

This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Retinal Consultants of Phoenix, Phoenix, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice

Exclusion criteria

  • None

Treatment and study plan

dexamethasone 700 ㎍ intravitreal implant

Drug

Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.

Other names: OZURDEX®

Primary outcomes

  1. Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, 12 Months

  2. Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye

    Time frame: Baseline, 12 Months

  3. Average Change from Baseline in BCVA in the Study Eye

    Time frame: Baseline, 12 Months

Secondary outcomes

  1. Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye

    Time frame: Baseline, 12 Months

  2. Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye

    Time frame: Baseline, 12 Months

  3. Percentage of Patients with BCVA of 20/40 or Better in the Study Eye

    Time frame: Baseline, 12 Months

  4. Mean Number of Ozurdex Injections in the Study Eye

    Time frame: 12 Months

  5. Mean Time Between Ozurdex Injections in the Study Eye

    Time frame: 12 Months

  6. Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye

    Time frame: Baseline, 12 Months

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 11, 2014
Registry last updated
Jun 1, 2016

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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