Back to resultsA 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Primary Purpose
Macular Edema, Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone intravitreal implant
Steroid plus NSAID eye drop combination therapy
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema
Eligibility Criteria
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.
Sites / Locations
- Retinal Consultants of Arizona
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OZURDEX intraocular implant
Steroid plus NSAID eye drop combination therapy
Arm Description
OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
Outcomes
Primary Outcome Measures
Mean Change in Best Corrected Visual Acuity
Mean Change in Best Corrected Visual Acuity
Mean Change in Best Corrected Visual Acuity
Mean Change in Central Retinal Thickness
Mean Change in Central Retinal Thickness
Mean Change in Central Retinal Thickness
Mean Change in Intraocular Pressure
Secondary Outcome Measures
Full Information
NCT ID
NCT01673191
First Posted
August 22, 2012
Last Updated
February 20, 2017
Sponsor
Retinal Consultants of Arizona
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01673191
Brief Title
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Official Title
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Retinal Consultants of Arizona
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OZURDEX intraocular implant
Arm Type
Experimental
Arm Description
OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg
Arm Title
Steroid plus NSAID eye drop combination therapy
Arm Type
Active Comparator
Arm Description
NSAID eye drop: Acular LS Steriod eye drop: Pred Forte
Intervention Type
Drug
Intervention Name(s)
Dexamethasone intravitreal implant
Other Intervention Name(s)
OZURDEX
Intervention Type
Drug
Intervention Name(s)
Steroid plus NSAID eye drop combination therapy
Other Intervention Name(s)
Acular LS and Pred Forte
Primary Outcome Measure Information:
Title
Mean Change in Best Corrected Visual Acuity
Time Frame
1 months
Title
Mean Change in Best Corrected Visual Acuity
Time Frame
2 months
Title
Mean Change in Best Corrected Visual Acuity
Time Frame
3 months
Title
Mean Change in Central Retinal Thickness
Time Frame
1 month
Title
Mean Change in Central Retinal Thickness
Time Frame
2 months
Title
Mean Change in Central Retinal Thickness
Time Frame
3 months
Title
Mean Change in Intraocular Pressure
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pravin U Dugel, MD
Organizational Affiliation
Retinal Consultants of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus
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