Back to resultsSafety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema, Vitrectomy
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Macular Edema
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older with diabetic macular edema
- History of vitrectomy
- Central retinal thickness ≥ 275 µm
- Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
Exclusion Criteria:
- Known anticipated need for ocular surgery during the study period
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Uncontrolled systemic disease
- Known allergy to the study medication
- Known steroid-responder
- Use of systemic steroids
- Female subjects that are pregnant, nursing or planning a pregnancy
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
700 µg Dexamethasone Implant
Arm Description
700 µg dexamethasone implant in the study eye at Day 1
Outcomes
Primary Outcome Measures
Change From Baseline in Central Retinal Thickness in the Study Eye
Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
Secondary Outcome Measures
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.
Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00799227
Brief Title
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2009 (Actual)
Primary Completion Date
December 1, 2009 (Actual)
Study Completion Date
December 1, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant in the study eye of vitrectomized subjects with diabetic macular edema. Subjects will be followed for 26 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema, Vitrectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
700 µg Dexamethasone Implant
Arm Type
Experimental
Arm Description
700 µg dexamethasone implant in the study eye at Day 1
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Posurdex®, OZURDEX®
Intervention Description
700 µg Dexamethasone Posterior Segment Drug Delivery System Applicator System at Day 1 in the study eye.
Primary Outcome Measure Information:
Title
Change From Baseline in Central Retinal Thickness in the Study Eye
Description
Central retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). OCT is a laser-based, noninvasive, diagnostic system that provides high-resolution, three-dimensional images of the retina from which retinal thickness can be measured. A negative change from baseline in retinal thickness indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase from baseline in the number of letters read correctly indicates improvement and a decrease from baseline in the number of letters read correctly indicates a worsening.
Time Frame
Baseline, Week 26
Title
Percentage of Patients With at Least 10 Letters of Improvement in BCVA From Baseline in the Study Eye
Description
BCVA is measured in the study eye using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Time Frame
Baseline, Week 26
Title
Percentage of Patients With Fluorescein Leakage as Measured by Fluorescein Angiography (FA) in the Study Eye
Description
Fluorescein leakage is measured in the study eye by FA. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. The assessment of fluorescein leakage compared to baseline is categorized as Improved (leakage area decreased ≥ 10%), Unchanged (leakage area changed < 10%), and Worsened (leakage area increased ≥ 10%).
Time Frame
Baseline, Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age or older with diabetic macular edema
History of vitrectomy
Central retinal thickness ≥ 275 µm
Visual acuity between 20/320 and 20/40 in the study eye and no worse than 20/200 in the other eye
Exclusion Criteria:
Known anticipated need for ocular surgery during the study period
History of glaucoma or current high eye pressure requiring more than 1 medication
Uncontrolled systemic disease
Known allergy to the study medication
Known steroid-responder
Use of systemic steroids
Female subjects that are pregnant, nursing or planning a pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Charlotte
State/Province
North Carolina
Country
United States
City
Sydney
State/Province
New South Wales
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
21487341
Citation
Boyer DS, Faber D, Gupta S, Patel SS, Tabandeh H, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex CHAMPLAIN Study Group. Dexamethasone intravitreal implant for treatment of diabetic macular edema in vitrectomized patients. Retina. 2011 May;31(5):915-23. doi: 10.1097/IAE.0b013e318206d18c.
Results Reference
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Learn more about this trial
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
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