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

Allergan

Status and phase: Completed; Phase 1

Conditions: Vitrectomy

Treatments: Drug: 200 µg Brimonidine Tartrate Implant; Drug: 400 µg Brimonidine Tartrate Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT01229410

190342-036

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

400 µg Brimonidine Tartrate Implant

Experimental group

Description:

400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Treatment:

Drug: 400 µg Brimonidine Tartrate Implant

200 µg Brimonidine Tartrate Implant

Experimental group

Description:

200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).

Treatment:

Drug: 200 µg Brimonidine Tartrate Implant