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

Vitrectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01229410
• Other study ID #: 190342-036
• Status: Completed
• Phase: Phase 1
• First received: October 20, 2010
• Last updated: July 2, 2013
• Start date: December 2010
• Est. completion date: October 2011

Study information

• Verified date: July 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vitrectomy

Intervention

Drug:
• 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 in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Highest Vitreous Humor Level of Brimonidine in the Study Eye	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.	60 Days	No
Secondary	Highest Aqueous Humor Level of Brimonidine in the Study Eye	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.	60 Days	No
Secondary	Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)	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.	60 Days	No