A Study to Evaluate an Updated Dexamethasone Intravitreal (Into the Eye) Applicator in Adult Participants With Macular Edema Due to Diseases of the Retina
NCT ID: NCT04976777
Last Updated: 2023-02-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
54 participants
INTERVENTIONAL
2021-10-12
2022-02-09
Brief Summary
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The DEX PS DDS is approved for the treatment of macular edema. Participants will be placed into 1 of 2 groups, called treatment arms. Each group receives the same treatment drug delivered using different applicators. Around 54 adult participants with macular edema will be enrolled in the study in approximately 7-10 sites in the United States.
Participants will receive a single intravitreal (into the eye) administration of DEX PS DDS implant using either the currently-approved DEX PS DDS Applicator or the the updated Applicator. The participants will be observed for a duration of 7 days, with the DEX PS DDS implant received on day 1 and follow-up through day 7.
The updates being evaluated in this study are related to the DEX PS DDS Applicator only, with the safety and efficacy of the DEX PS DDS implant well characterized and the same as the currently marketed product. Participants will attend regular visits during the study at a hospital or clinic. The applicator function will be checked by medical assessment, checking for side effects, procedural complications and/or product complaints, and evaluating the administration procedure.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Updated Dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) 0.7 mg
DEX PS DDS 0.7 mg implant was administered intravitreally into the study eye using updated applicator at Day 1 and followed until Day 7.
Updated DEX PS DDS Applicator
Intravitreal Administration
Dexamethasone
Dexamethasone 0.7 mg in a solid polymer drug delivery system
Approved DEX PS DDS 0.7 mg
DEX PS DDS 0.7 mg implant was administered into the study eye using currently approved applicator at Day 1 and followed until Day 7.
Approved DEX PS DDS Applicator
Intravitreal administration
Dexamethasone
Dexamethasone 0.7 mg in a solid polymer drug delivery system
Interventions
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Updated DEX PS DDS Applicator
Intravitreal Administration
Approved DEX PS DDS Applicator
Intravitreal administration
Dexamethasone
Dexamethasone 0.7 mg in a solid polymer drug delivery system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ALLERGAN INC.
Role: STUDY_DIRECTOR
Allergan
Locations
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Global Research Management /ID# 238944
Glendale, California, United States
Advanced Eye Centers Inc /ID# 233429
North Dartmouth, Massachusetts, United States
Discover Vision Centers /ID# 239366
Independence, Missouri, United States
Charleston Neurosciences Institute /ID# 238521
Charleston, South Carolina, United States
Retina Research Institute of Texas /ID# 231420
Abilene, Texas, United States
Texas Retina Associates /ID# 231305
Arlington, Texas, United States
North Texas Retina Consultants /ID# 241013
Willow Park, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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1491-801-007
Identifier Type: -
Identifier Source: org_study_id
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