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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02188173
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
Allergan

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

Condition or disease Intervention/treatment
Macular Edema Drug: dexamethasone 700 ㎍ intravitreal implant

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : July 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Group/Cohort Intervention/treatment
dexamethasone 700 ㎍ intravitreal implant
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.
Drug: dexamethasone 700 ㎍ intravitreal implant
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 Name: OZURDEX®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None

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): NCT02188173


Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02188173    
Other Study ID Numbers: GMA-US-EYE-0272
REINFORCE ( Other Identifier: Allergan )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Macular Edema
Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
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