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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT02188173
Collaborator
(none)
200
Enrollment
18
Locations
22
Duration (Months)
11.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: dexamethasone 700 ㎍ intravitreal implant

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm 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 Names:
  • OZURDEX®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Maximum Change from Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye [Baseline, 12 Months]

    2. Percentage of Patients with a BCVA Improvement of ≥15 Letters in the Study Eye [Baseline, 12 Months]

    3. Average Change from Baseline in BCVA in the Study Eye [Baseline, 12 Months]

    Secondary Outcome Measures

    1. Percentage of Patients with an Increase from Baseline of ≥2 Lines in BCVA in the Study Eye [Baseline, 12 Months]

    2. Percentage of Patients with an Increase from Baseline of ≥3 Lines in BCVA in the Study Eye [Baseline, 12 Months]

    3. Percentage of Patients with BCVA of 20/40 or Better in the Study Eye [Baseline, 12 Months]

    4. Mean Number of Ozurdex Injections in the Study Eye [12 Months]

    5. Mean Time Between Ozurdex Injections in the Study Eye [12 Months]

    6. Change from Baseline in Central Retinal Subfield Thickness (CRT) in the Study Eye [Baseline, 12 Months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Diagnosis of DME in at least one eye treated OZURDEX® per clinical practice
    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Retinal Consultants of Phoenix Phoenix Arizona United States 85014
    2 West Coast Retina San Francisco California United States 94109
    3 Orange Co Retina Medical Group Santa Ana California United States 92705
    4 Bay Area Retina Associates Walnut Creek California United States 94598
    5 Colorado Retina Associates Denver Colorado United States 80230
    6 Illinois Retina Associates Harvey Illinois United States 60426
    7 Raj Maturi, MD PC Indianapolis Indiana United States 46290
    8 John-Kenyon American Eye Institute New Albany Indiana United States 47150
    9 Associated Retina Consultants Royal Oak Michigan United States 48073
    10 Associated Retinal Consultants, PC Traverse City Michigan United States 69686
    11 Lifelong Vision Foundation Chesterfield Missouri United States 63017
    12 Eyesight Ophthalmic Services Portsmouth New Hampshire United States 03801
    13 New Jersey Retina New Brunswick New Jersey United States 08901
    14 Long Island Vitreoretinal Consultants - Long Island Retina - Hauppauge Great Neck New York United States 11201
    15 Mid Atlantic Retina Philadelphia Pennsylvania United States 19109
    16 Texas Retina Associates, Arlington Arlington Texas United States 76012
    17 Valley Retina Institute, P.A. McAllen Texas United States 78503
    18 Medical Center Ophthalmology Associates San Antonio Texas United States 78240

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Medical Director, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT02188173
    Other Study ID Numbers:
    • GMA-US-EYE-0272
    • REINFORCE
    First Posted:
    Jul 11, 2014
    Last Update Posted:
    Jun 1, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Macular Edema
    Edema
    Dexamethasone

    Study Results

    No Results Posted as of Jun 1, 2016