Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitrectomy
Intervention: 400 µg Brimonidine Tartrate Implant (Drug); 200 µg Brimonidine Tartrate Implant (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s): Medical Director, Study Director, Affiliation: Allergan
Summary
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.
Clinical Details
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Primary outcome: Highest Vitreous Humor Level of Brimonidine in the Study Eye
Secondary outcome: Highest Aqueous Humor Level of Brimonidine in the Study EyePercentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Prague, Czech Republic
Salt Lake City, Utah, United States
Additional Information
Starting date: December 2010
Last updated: July 2, 2013
|