- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01229410
Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
July 2, 2013 updated by: Allergan
This study will evaluate the pharmacokinetics of brimonidine following a single intravitreal administration of the 200 ug or 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System in patients 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czech Republic
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Plan on having a pars plana vitrectomy for repair of a posterior segment condition (eg, epiretinal membrane, macular hole, vitreomacular traction)
- Visual acuity in the non-study eye better than 20/200
Exclusion Criteria:
- History of pars plana vitrectomy or retinal detachment surgery in the study eye
- Surgery or laser treatment in the study eye within 3 months
- Use of brimonidine, apraclonidine or other topical alpha-2-agonist in either eye within 2 weeks
- Intraocular infection or inflammation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
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400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Other Names:
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EXPERIMENTAL: 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
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200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Highest Vitreous Humor Level of Brimonidine in the Study Eye
Time Frame: 60 Days
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The highest level of brimonidine measured in the vitreous humor of the study eye in any patient is reported for each treatment arm.
The vitreous humor is the clear gel that fills the space between the lens and the retina of the eye.
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60 Days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Highest Aqueous Humor Level of Brimonidine in the Study Eye
Time Frame: 60 Days
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The highest level of brimonidine measured in the aqueous humor of the study eye in any patient is reported for each treatment arm.
The aqueous humor is the clear fluid in the chamber of the eye between the cornea and the lens.
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60 Days
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Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)
Time Frame: 60 Days
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Percentage of patient samples with plasma levels of brimonidine reported as BLQ (i.e., too low to be determined using standard methods).
Plasma is the fluid portion of the blood.
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60 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
May 1, 2011
Study Completion (ACTUAL)
October 1, 2011
Study Registration Dates
First Submitted
October 20, 2010
First Submitted That Met QC Criteria
October 26, 2010
First Posted (ESTIMATE)
October 27, 2010
Study Record Updates
Last Update Posted (ESTIMATE)
August 5, 2013
Last Update Submitted That Met QC Criteria
July 2, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 190342-036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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