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

October 20, 2010
July 2, 2013
December 2010
May 2011   (final data collection date for primary outcome measure)
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.
Vitreous Levels of Brimonidine [ Time Frame: Day of Pars Plana Vitrectomy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01229410 on ClinicalTrials.gov Archive Site
  • 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.
Plasma Levels of Brimonidine [ Time Frame: Day of Pars Plana Vitrectomy ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Pharmacokinetics of the Brimonidine Tartrate Posterior Segment Delivery System in Patients Undergoing Pars Plana Vitrectomy
Not Provided

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
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®
  • 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®
  • 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).
    Intervention: Drug: 400 µg Brimonidine Tartrate Implant
  • 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).
    Intervention: Drug: 200 µg Brimonidine Tartrate Implant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Czech Republic
 
NCT01229410
190342-036
No
Allergan
Allergan
Not Provided
Study Director: Medical Director Allergan
Allergan
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP