Macular EdemaNCT02188173
An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)
An observational study of Macular Edema, run by Allergan at 18 sites in United States.
Trial summary
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- dexamethasone 700 ㎍ intravitreal implant
- How many people
- 200 participants
- Where
- 18 sitesUnited States
- Study dates
- Jul 2014to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.
Who may be able to join
- Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
Who cannot join
- None
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Texas Retina Associates, Arlington
Arlington, Texas, 76012
Lifelong Vision Foundation
Chesterfield, Missouri, 63017
Colorado Retina Associates
Denver, Colorado, 80230
Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge
Great Neck, New York, 11201
Illinois Retina Associates
Harvey, Illinois, 60426
Raj Maturi, MD PC
Indianapolis, Indiana, 46290
Valley Retina Institute, P.A.
McAllen, Texas, 78503
John-Kenyon American Eye Institute
New Albany, Indiana, 47150
New Jersey Retina
New Brunswick, New Jersey, 08901
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19109
Retinal Consultants of Phoenix
Phoenix, Arizona, 85014
Eyesight Ophthalmic Services
Portsmouth, New Hampshire, 03801
Associated Retina Consultants
Royal Oak, Michigan, 48073
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
West Coast Retina
San Francisco, California, 94109
Orange Co Retina Medical Group
Santa Ana, California, 92705
Associated Retinal Consultants, PC
Traverse City, Michigan, 69686
Bay Area Retina Associates
Walnut Creek, California, 94598
About this study
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).
- Conditions
- Macular Edema
- Being tested
- dexamethasone 700 ㎍ intravitreal implant
- Medical subject headings
- Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexamethasone 700 ㎍ intravitreal implantDrug
Also called OZURDEX®
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: dexamethasone 700 ㎍ intravitreal implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Measured: Baseline, 12 Months
Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye
Measured: Baseline, 12 Months
Average Change from Baseline in BCVA in the Study Eye
Measured: Baseline, 12 Months
Secondary outcomes (6)
Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye
Measured: Baseline, 12 Months
Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye
Measured: Baseline, 12 Months
Percentage of Patients with BCVA of 20/40 or Better in the Study Eye
Measured: Baseline, 12 Months
Mean Number of Ozurdex Injections in the Study Eye
Measured: 12 Months
Mean Time Between Ozurdex Injections in the Study Eye
Measured: 12 Months
Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye
Measured: Baseline, 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02188173
- Sponsor's protocol ID
- GMA-US-EYE-0272
- Other IDs
- REINFORCE
- Status last verified
- May 2016
- First submitted
- 10 Jul 2014
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study of OZURDEX® in Diabetic Macular Edema (DME)
- ClinicalTrials.gov ID
- NCT02188173
- Acronym / sponsor ID
- GMA-US-EYE-0272
- Conditions
- Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 11 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of OZURDEX® use in clinical practice in patients with diabetic macular edema (DME).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexamethasone 700 ㎍ intravitreal implant | – | Drug: dexamethasone 700 ㎍ intravitreal implantPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetic macular edema (DME) treated with (OZURDEX®) in clinical practice.
Key inclusion criteria (1 listed)
- Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dexamethasone 700 ㎍ intravitreal implantAlso: OZURDEX®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 |
Primary outcome
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
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema, run by Allergan at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye (time frame: Baseline, 12 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2016.