Back to resultsSafety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dexamethasone
Sham injection
Laser Photocoagulation
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
- Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
- Visual acuity in other eye no worse than 20/200
Exclusion Criteria:
- Known anticipated need for ocular surgery within next 12 months
- History of glaucoma or current high eye pressure requiring more than 1 medication
- Uncontrolled systemic disease
- Known steroid-responder
- Use of systemic steroids - Use of Warfarin/Heparin
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
700 µg Dexamethasone Implant and Laser Photocoagulation
Sham Implant and Laser Photocoagulation
Arm Description
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Outcomes
Primary Outcome Measures
Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (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.
Secondary Outcome Measures
Change From Baseline in 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 in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.
Change From Baseline in Central Subfield Retinal Thickness in the Study Eye
Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). 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 number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Change From Baseline in the Focal Leakage Area in the Study Eye
Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.
Time to Retreatment in the Study Eye
Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00464685
Brief Title
Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2007 (Actual)
Primary Completion Date
February 8, 2010 (Actual)
Study Completion Date
February 8, 2010 (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
This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with laser treatment vs. laser treatment alone in patients with diabetic macular edema.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
253 (Actual)
8. Arms, Groups, and Interventions
Arm Title
700 µg Dexamethasone Implant and Laser Photocoagulation
Arm Type
Experimental
Arm Description
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Arm Title
Sham Implant and Laser Photocoagulation
Arm Type
Sham Comparator
Arm Description
Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Posurdex®
Intervention Description
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
Intervention Type
Drug
Intervention Name(s)
Sham injection
Intervention Description
Initial sham injection with up to 1 additional treatment based on re-treatment criteria.
Intervention Type
Procedure
Intervention Name(s)
Laser Photocoagulation
Intervention Description
Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Primary Outcome Measure Information:
Title
Percentage of Patients With at Least 10 Letters of Improvement in Best Corrected Visual Acuity (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, Month 12
Secondary Outcome Measure Information:
Title
Change From Baseline in 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 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, Month 12
Title
Change From Baseline in Central Subfield Retinal Thickness in the Study Eye
Description
Central subfield retinal thickness is assessed in the study eye by Optical Coherence Tomography (OCT). The central subfield is an area in the retina (back of the eye). 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 number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
Time Frame
Baseline, Month 12
Title
Change From Baseline in the Focal Leakage Area in the Study Eye
Description
Focal leakage area in the study eye is assessed using fluorescein angiography. A positive number change from baseline indicates a worsening and a negative number change from baseline indicates an improvement.
Time Frame
Baseline, Month 12
Title
Time to Retreatment in the Study Eye
Description
Time to retreatment in the study eye is defined as the number of days between the initial treatment and re-treatment with the study medication.
Time Frame
12 Months
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
Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)
Visual acuity in other eye no worse than 20/200
Exclusion Criteria:
Known anticipated need for ocular surgery within next 12 months
History of glaucoma or current high eye pressure requiring more than 1 medication
Uncontrolled systemic disease
Known steroid-responder
Use of systemic steroids - Use of Warfarin/Heparin
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Artesia
State/Province
California
Country
United States
City
Victoria
State/Province
British Columbia
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
23706947
Citation
Callanan DG, Gupta S, Boyer DS, Ciulla TA, Singer MA, Kuppermann BD, Liu CC, Li XY, Hollander DA, Schiffman RM, Whitcup SM; Ozurdex PLACID Study Group. Dexamethasone intravitreal implant in combination with laser photocoagulation for the treatment of diffuse diabetic macular edema. Ophthalmology. 2013 Sep;120(9):1843-51. doi: 10.1016/j.ophtha.2013.02.018. Epub 2013 May 22.
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Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
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