Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy

Completed · Phase 1

Conditions studied: Vitrectomy

In brief

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.

Key facts

Study ID

NCT01229410

Run by

Allergan

People needed

24

Starts

2010-12-01

Expected to finish

2011-10-01

Last updated by the study team

2013-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Salt Lake City, Utah, United States
• Study site — Prague, Czechia

Full record on ClinicalTrials.gov

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