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OpenTrials
Completed

NCT Number: NCT01229410

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

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.

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Key information

Conditions

Vitrectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Prague, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

400 µg Brimonidine Tartrate Implant

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).

Other names: Brimonidine Tartrate PS DDS®

200 µg Brimonidine Tartrate Implant

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).

Other names: Brimonidine Tartrate PS DDS®

Primary outcomes

  1. Highest Vitreous Humor Level of Brimonidine in the Study Eye

    Time frame: 60 Days

    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 outcomes

  1. Highest Aqueous Humor Level of Brimonidine in the Study Eye

    Time frame: 60 Days

    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.

  2. Percentage of Patient Samples With Plasma Levels of Brimonidine Below the Limit of Quantitation (BLQ)

    Time frame: 60 Days

    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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 27, 2010
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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