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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01229410
First received: October 20, 2010
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitrectomy
 Drug: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery System
Drug: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System
 Phase 1

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Vitreous Levels of Brimonidine [ Time Frame: Day of Pars Plana Vitrectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma Levels of Brimonidine [ Time Frame: Day of Pars Plana Vitrectomy ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: December 2010
Study Completion Date: October 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 200 ug brimonidine tartrate
200 ug brimonidine tartrate
 Drug: 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery System
The 200 ug Brimonidine Tartrate Posterior Segment Drug Delivery System administered to the study eye on Day 1 which is 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.
Experimental: 400 ug brimonidine tartrate
400 ug brimonidine tartrate
 Drug: 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System
The 400 ug Brimonidine Tartrate Posterior Segment Drug Delivery System administered to the study eye on Day 1 which is 2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01229410

Locations
United States, Utah
Salt Lake City, Utah, United States
Czech Republic
Prague, Czech Republic
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01229410     History of Changes
Other Study ID Numbers: 190342-036
Study First Received: October 20, 2010
Last Updated: April 27, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013