Safety and Efficacy of a New Therapy as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) in Subjects With Wet Age-Related Macular Degeneration (AMD)
NCT ID: NCT00775411
Last Updated: 2012-09-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2008-11-30
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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700 µg dexamethasone and ranibizumab
700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
dexamethasone
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
ranibizumab
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Interventions
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dexamethasone
700 µg dexamethasone intravitreal injection at Day 1 in the study eye.
ranibizumab
Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Central retinal thickness ≥ 300 µm
* Visual acuity between 20/400 and 20/32
* Eligible for Anti-VEGF therapy
Exclusion Criteria
* High eye pressure
* Glaucoma
* Uncontrolled systemic disease
* Known allergy to the study medications
* Recent eye surgery or injections in the eye
* Female subjects that are of childbearing potential
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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San Antonio, Texas, United States
Sydney, New South Wales, Australia
Manila, , Philippines
Countries
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Other Identifiers
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206207-019
Identifier Type: -
Identifier Source: org_study_id