An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)
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ClinicalTrials.gov Identifier: NCT02188173 |
Recruitment Status :
Completed
First Posted : July 11, 2014
Last Update Posted : June 1, 2016
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Condition or disease | Intervention/treatment |
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Macular Edema | Drug: dexamethasone 700 ㎍ intravitreal implant |
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 |
Group/Cohort | Intervention/treatment |
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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.
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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® |
- Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [ Time Frame: Baseline, 12 Months ]
- Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye [ Time Frame: Baseline, 12 Months ]
- Average Change from Baseline in BCVA in the Study Eye [ Time Frame: Baseline, 12 Months ]
- Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye [ Time Frame: Baseline, 12 Months ]
- Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye [ Time Frame: Baseline, 12 Months ]
- Percentage of Patients with BCVA of 20/40 or Better in the Study Eye [ Time Frame: Baseline, 12 Months ]
- Mean Number of Ozurdex Injections in the Study Eye [ Time Frame: 12 Months ]
- Mean Time Between Ozurdex Injections in the Study Eye [ Time Frame: 12 Months ]
- Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye [ Time Frame: Baseline, 12 Months ]

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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 |
Inclusion Criteria:
- Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
Exclusion Criteria:
- None

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

Study Director: | Medical Director | Allergan |
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 |
Macular Edema Edema 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 |