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

NCT ID: NCT01229410

Last Updated: 2013-08-05

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Vitrectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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).

Group Type EXPERIMENTAL

400 µg Brimonidine Tartrate Implant

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

200 µg Brimonidine Tartrate Implant

Intervention Type DRUG

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

Interventions

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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).

Intervention Type DRUG

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).

Intervention Type DRUG

Other Intervention Names

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Brimonidine Tartrate PS DDS® Brimonidine Tartrate PS DDS®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Salt Lake City, Utah, United States

Site Status

Prague, , Czechia

Site Status

Countries

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United States Czechia

Other Identifiers

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190342-036

Identifier Type: -

Identifier Source: org_study_id