Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema
NCT ID: NCT01492400
Last Updated: 2019-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
363 participants
INTERVENTIONAL
2012-03-09
2014-02-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
Interventions
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dexamethasone Intravitreal Implant
Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
ranibizumab
Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of macular edema
* Visual acuity between 20/200 to 20/40
Exclusion Criteria
* Use of Ozurdex® within 9 months
* Any active ocular inflammation and infection
* Diagnosis of glaucoma
* Use of anti-VEGF treatment (e.g., Lucentis®) within 3 months in the eye or systemic use (e.g., Avastin®) within 6 months
18 Years
ALL
No
Sponsors
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Allergan
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Allergan
Locations
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Arlington, Texas, United States
Brussels, , Belgium
Copenhagen, , Denmark
Glostrup Municipality, , Denmark
Paris, , France
Ahaus, , Germany
Tel Aviv, , Israel
Udine, , Italy
Nijmegen, , Netherlands
Coimbra, , Portugal
Pretoria, , South Africa
Barcelona, , Spain
London, England, United Kingdom
Countries
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References
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Callanan DG, Loewenstein A, Patel SS, Massin P, Corcostegui B, Li XY, Jiao J, Hashad Y, Whitcup SM. A multicenter, 12-month randomized study comparing dexamethasone intravitreal implant with ranibizumab in patients with diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2017 Mar;255(3):463-473. doi: 10.1007/s00417-016-3472-1. Epub 2016 Sep 8.
Rittiphairoj T, Mir TA, Li T, Virgili G. Intravitreal steroids for macular edema in diabetes. Cochrane Database Syst Rev. 2020 Nov 17;11(11):CD005656. doi: 10.1002/14651858.CD005656.pub3.
Chakravarthy H, Devanathan V. Molecular Mechanisms Mediating Diabetic Retinal Neurodegeneration: Potential Research Avenues and Therapeutic Targets. J Mol Neurosci. 2018 Nov;66(3):445-461. doi: 10.1007/s12031-018-1188-x. Epub 2018 Oct 6.
Other Identifiers
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206207-024
Identifier Type: -
Identifier Source: org_study_id
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