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

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188173
• Other study ID #: GMA-US-EYE-0272
• Secondary ID: REINFORCE
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: May 31, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Edema

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Retina Associates, Arlington	Arlington	Texas
United States	Lifelong Vision Foundation	Chesterfield	Missouri
United States	Colorado Retina Associates	Denver	Colorado
United States	Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge	Great Neck	New York
United States	Illinois Retina Associates	Harvey	Illinois
United States	Raj Maturi, MD PC	Indianapolis	Indiana
United States	Valley Retina Institute, P.A.	McAllen	Texas
United States	John-Kenyon American Eye Institute	New Albany	Indiana
United States	New Jersey Retina	New Brunswick	New Jersey
United States	Mid Atlantic Retina	Philadelphia	Pennsylvania
United States	Retinal Consultants of Phoenix	Phoenix	Arizona
United States	Eyesight Ophthalmic Services	Portsmouth	New Hampshire
United States	Associated Retina Consultants	Royal Oak	Michigan
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	West Coast Retina	San Francisco	California
United States	Orange Co Retina Medical Group	Santa Ana	California
United States	Associated Retinal Consultants, PC	Traverse City	Michigan
United States	Bay Area Retina Associates	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye		Baseline, 12 Months	No
Primary	Percentage of Patients with a BCVA Improvement of =15 Letters in the Study Eye		Baseline, 12 Months	No
Primary	Average Change from Baseline in BCVA in the Study Eye		Baseline, 12 Months	No
Secondary	Percentage of Patients with an Increase from Baseline of =2 Lines in BCVA in the Study Eye		Baseline, 12 Months	No
Secondary	Percentage of Patients with an Increase from Baseline of =3 Lines in BCVA in the Study Eye		Baseline, 12 Months	No
Secondary	Percentage of Patients with BCVA of 20/40 or Better in the Study Eye		Baseline, 12 Months	No
Secondary	Mean Number of Ozurdex Injections in the Study Eye		12 Months	No
Secondary	Mean Time Between Ozurdex Injections in the Study Eye		12 Months	No
Secondary	Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye		Baseline, 12 Months	No