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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


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 Eye

Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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

Page last updated: August 20, 2015

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