Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
1 other identifier
interventional
253
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2007
CompletedFirst Posted
Study publicly available on registry
April 24, 2007
CompletedStudy Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 8, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 8, 2010
CompletedResults Posted
Study results publicly available
August 4, 2014
CompletedApril 24, 2019
April 1, 2019
2.8 years
April 20, 2007
July 10, 2014
April 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Month 12
Secondary Outcomes (4)
Change From Baseline in BCVA in the Study Eye
Baseline, Month 12
Change From Baseline in Central Subfield Retinal Thickness in the Study Eye
Baseline, Month 12
Change From Baseline in the Focal Leakage Area in the Study Eye
Baseline, Month 12
Time to Retreatment in the Study Eye
12 Months
Study Arms (2)
700 µg Dexamethasone Implant and Laser Photocoagulation
EXPERIMENTALInitial 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.
Sham Implant and Laser Photocoagulation
SHAM COMPARATORInitial 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.
Interventions
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Allerganlead
Study Sites (2)
Unknown Facility
Artesia, California, United States
Unknown Facility
Victoria, British Columbia, Canada
Related Publications (1)
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.
PMID: 23706947BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Therapeutic Area Head,
- Organization
- Allergan, Inc
Study Officials
- STUDY DIRECTOR
Medical Director
Allergan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2007
First Posted
April 24, 2007
Study Start
May 1, 2007
Primary Completion
February 8, 2010
Study Completion
February 8, 2010
Last Updated
April 24, 2019
Results First Posted
August 4, 2014
Record last verified: 2019-04