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

Phase 1

Completed

• Conditions: Vitrectomy
• Interventions: Drug: 400 µg Brimonidine Tartrate Implant; Drug: 200 µg Brimonidine Tartrate Implant

• Registration Number: NCT01229410
• Lead Sponsor: Allergan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-26
• Study First Posted: 2010-10-27
• Study Start: 2010-12
• Primary Completion: 2011-05
• Study Completion: 2011-10
• Results First Submitted: 2013-03-13
• Status Verified: 2013-07
• Results First Submitted QC: 2013-07-02
• Last Update Submitted: 2013-07-02
• Results First Posted: 2013-08-05
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
400 µg Brimonidine Tartrate Implant	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).
200 µg Brimonidine Tartrate Implant	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).

Primary Outcome Measures

Name	Time	Method
Highest Vitreous Humor Level of Brimonidine in the Study Eye	60 Days	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.

Secondary Outcome Measures

Name	Time	Method
Highest Aqueous Humor Level of Brimonidine in the Study Eye	60 Days	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.
Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)	60 Days	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.