Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)
NCT ID: NCT00511706
Last Updated: 2019-04-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
243 participants
INTERVENTIONAL
2007-11-01
2009-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
TRIPLE
Study Groups
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dexamethasone and ranibizumab
Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
dexamethasone
Intravitreal injection of dexamethasone 700 µg at Day 1.
ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.
sham and ranibizumab
Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.
sham
Sham needle-less injection administered in the study eye at Day 1.
Interventions
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dexamethasone
Intravitreal injection of dexamethasone 700 µg at Day 1.
ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.
sham
Sham needle-less injection administered in the study eye at Day 1.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual Acuity between 20/40 and 20/400 in the study eye
Exclusion Criteria
* Glaucoma
* Cataract
* High eye pressure
* Uncontrolled systemic disease
50 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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Boynton Beach, Florida, United States
Parramatta, New South Wales, Australia
Paris, , France
Tel Aviv, , Israel
Milan, , Italy
Auckland, , New Zealand
Coimbra, , Portugal
Seoul, , South Korea
Southampton, Hampshire, United Kingdom
Countries
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References
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Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex(R) ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18.
Other Identifiers
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206207-016
Identifier Type: -
Identifier Source: org_study_id
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