Overview

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

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Allergan
Treatments:
Brimonidine Tartrate
Temazepam
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