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: July 2, 2013
Last verified: July 2013
  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: 400 µg Brimonidine Tartrate Implant
Drug: 200 µg Brimonidine Tartrate Implant
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:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Highest Vitreous Humor Level of Brimonidine in the Study Eye [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    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:
  • Highest Aqueous Humor Level of Brimonidine in the Study Eye [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    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) [ Time Frame: 60 Days ] [ Designated as safety issue: No ]
    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.


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: 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).
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).
Other Name: Brimonidine Tartrate PS DDS®
Experimental: 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).
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).
Other Name: Brimonidine Tartrate PS DDS®

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: March 13, 2013
Last Updated: July 2, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 23, 2014