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

May 31, 2016 updated by: Allergan
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85014
        • Retinal Consultants of Phoenix
    • California
      • San Francisco, California, United States, 94109
        • West Coast Retina
      • Santa Ana, California, United States, 92705
        • Orange Co Retina Medical Group
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates
    • Colorado
      • Denver, Colorado, United States, 80230
        • Colorado Retina Associates
    • Illinois
      • Harvey, Illinois, United States, 60426
        • Illinois Retina Associates
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Raj Maturi, MD PC
      • New Albany, Indiana, United States, 47150
        • John-Kenyon American Eye Institute
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • Associated Retina Consultants
      • Traverse City, Michigan, United States, 69686
        • Associated Retinal Consultants, PC
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Lifelong Vision Foundation
    • New Hampshire
      • Portsmouth, New Hampshire, United States, 03801
        • EyeSight Ophthalmic Services
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • New Jersey Retina
    • New York
      • Great Neck, New York, United States, 11201
        • Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19109
        • Mid Atlantic Retina
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates, Arlington
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, P.A.
      • San Antonio, Texas, United States, 78240
        • Medical Center Ophthalmology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • OZURDEX®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Time Frame: Baseline, 12 Months
Baseline, 12 Months
Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye
Time Frame: Baseline, 12 Months
Baseline, 12 Months
Average Change from Baseline in BCVA in the Study Eye
Time Frame: Baseline, 12 Months
Baseline, 12 Months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye
Time Frame: Baseline, 12 Months
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
Baseline, 12 Months
Percentage of Patients with BCVA of 20/40 or Better in the Study Eye
Time Frame: Baseline, 12 Months
Baseline, 12 Months
Mean Number of Ozurdex Injections in the Study Eye
Time Frame: 12 Months
12 Months
Mean Time Between Ozurdex Injections in the Study Eye
Time Frame: 12 Months
12 Months
Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye
Time Frame: Baseline, 12 Months
Baseline, 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Allergan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GMA-US-EYE-0272
  • REINFORCE (Allergan)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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