A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema
NCT ID: NCT00168389
Last Updated: 2014-08-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
494 participants
INTERVENTIONAL
2005-02-28
2012-06-30
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
QUADRUPLE
Study Groups
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Dexamethasone 700 μg
700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Dexamethasone
350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Dexamethasone 350 μg
350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Dexamethasone
350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
Interventions
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Dexamethasone
350 µg or 700 µg dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
Sham
Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
Other Intervention Names
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Eligibility Criteria
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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
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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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Inglewood, California, United States
Westmead, New South Wales, Australia
Toronto, Ontario, Canada
Prague, , Czechia
Hamburg, , Germany
Tel Aviv, , Israel
Rockwell Center, Makati, , Philippines
Coimbra, , Portugal
Cape Town, , South Africa
Barcelona, , Spain
Countries
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References
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Kozak I, Do DV, Lai H, Ogidigben MJ, Lopez FJ. Time-in-Range Analysis of Responses after Intravitreal Dexamethasone Therapy in Eyes with Diabetic Macular Edema. Ophthalmol Sci. 2025 May 26;5(5):100833. doi: 10.1016/j.xops.2025.100833. eCollection 2025 Sep-Oct.
Valentim CCS, Lai H, Ogidigben MJ, Singh RP, Talcott KE. Baseline factors affecting diabetic macular oedema resolution after intravitreal dexamethasone implant treatment: post hoc analysis of the MEAD study. BMC Ophthalmol. 2025 Jul 9;25(1):403. doi: 10.1186/s12886-025-04208-3.
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.
Yoon YH, Boyer DS, Maturi RK, Bandello F, Belfort R Jr, Augustin AJ, Li XY, Bai Z, Hashad Y; Ozurdex MEAD Study Group. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study). Graefes Arch Clin Exp Ophthalmol. 2019 Dec;257(12):2639-2653. doi: 10.1007/s00417-019-04464-2. Epub 2019 Oct 25.
Danis RP, Sadda S, Li XY, Cui H, Hashad Y, Whitcup SM. Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials. Br J Ophthalmol. 2016 Jun;100(6):796-801. doi: 10.1136/bjophthalmol-2015-306823. Epub 2015 Nov 18.
Augustin AJ, Kuppermann BD, Lanzetta P, Loewenstein A, Li XY, Cui H, Hashad Y, Whitcup SM; Ozurdex MEAD Study Group. Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. BMC Ophthalmol. 2015 Oct 30;15:150. doi: 10.1186/s12886-015-0148-2.
Other Identifiers
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206207-010
Identifier Type: -
Identifier Source: org_study_id
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