Safety and Efficacy of a New Treatment in Combination With Laser for Diabetic Macular Edema
NCT ID: NCT00464685
Last Updated: 2019-04-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
253 participants
INTERVENTIONAL
2007-05-01
2010-02-08
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
NCT00168389
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
NCT00168298
A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema
NCT02121262
A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
NCT00168337
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Retinal Vein Occlusion
NCT00168324
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
700 µg Dexamethasone Implant and Laser Photocoagulation
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.
Dexamethasone
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
Laser Photocoagulation
Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Sham Implant and Laser Photocoagulation
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.
Sham injection
Initial sham injection with up to 1 additional treatment based on re-treatment criteria.
Laser Photocoagulation
Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Dexamethasone
Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria.
Sham injection
Initial sham injection with up to 1 additional treatment based on re-treatment criteria.
Laser Photocoagulation
Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allergan
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Artesia, California, United States
Victoria, British Columbia, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
206207-012
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.