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A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673191
First Posted: August 27, 2012
Last Update Posted: April 5, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by (Responsible Party):
Retinal Consultants of Arizona
August 22, 2012
August 27, 2012
February 20, 2017
April 5, 2017
April 5, 2017
November 2012
December 2014   (Final data collection date for primary outcome measure)
  • Mean Change in Best Corrected Visual Acuity [ Time Frame: 1 months ]
  • Mean Change in Best Corrected Visual Acuity [ Time Frame: 2 months ]
  • Mean Change in Best Corrected Visual Acuity [ Time Frame: 3 months ]
  • Mean Change in Central Retinal Thickness [ Time Frame: 1 month ]
  • Mean Change in Central Retinal Thickness [ Time Frame: 2 months ]
  • Mean Change in Central Retinal Thickness [ Time Frame: 3 months ]
  • Mean Change in Intraocular Pressure [ Time Frame: 3 months ]
Percentage of patients with significant decrease in OCT (e.g., 50-100 µm) following treatment with OZURDEX®. [ Time Frame: 3 months ]
Complete list of historical versions of study NCT01673191 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
The objective of this study is to assess the safety and efficacy of the OZURDEX® intraocular implant in patients with diabetes mellitus, who develop macular edema after cataract surgery
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Macular Edema
  • Diabetes Mellitus
  • Drug: Dexamethasone intravitreal implant
    Other Name: OZURDEX
  • Drug: Steroid plus NSAID eye drop combination therapy
    Other Name: Acular LS and Pred Forte
  • Experimental: OZURDEX intraocular implant
    OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
    Intervention: Drug: Dexamethasone intravitreal implant
  • Active Comparator: Steroid plus NSAID eye drop combination therapy
    NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
    Intervention: Drug: Steroid plus NSAID eye drop combination therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient has diagnosis of Diabetes Mellitus, Type I or II.
  • Patient has experienced the development of macular edema following cataract surgery in at least one eye.
  • Patient has had cataract surgery within 90 days prior to the screening visit.

Exclusion Criteria:

  • Patient has other significant ocular disease in study eye, including glaucoma.
  • Patient has any active infection in the study eye.
  • Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
  • Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
  • Patient has received the OZURDEX® implant before in the study eye.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01673191
RCA2012
No
Not Provided
Plan to Share IPD: No
Retinal Consultants of Arizona
Retinal Consultants of Arizona
Allergan
Principal Investigator: Pravin U Dugel, MD Retinal Consultants of Arizona
Retinal Consultants of Arizona
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP