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OpenTrials
Completed

NCT Number: NCT00972374

Safety and Efficacy of Brimonidine Tartrate Posterior Segment Drug Delivery System in Improving Visual Function

This study will evaluate the efficacy and safety of the Brimo PS DDS® Applicator System (200 μg and 400 μg brimonidine tartrate) on visual function in patients with previous rhegmatogenous macula-off retinal detachment.

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Key information

Conditions

Rhegmatogenous Macula-off Retinal Detachment

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Delhi, India

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The macula-off retinal detachment must have been caused by a rupture (rhegmatogenous in etiology)
  • The repair of the macula-off retinal detachment must have occurred at least 6 months before the Day 1 visit in the study eye
  • The repair must have been deemed an anatomic success and required no more than one macular re-attachment procedure
  • The visual acuity score must be between 20/50 and 20/320 in the study eye

Exclusion criteria

  • Any sight-threatening ocular condition in the study eye other than the ruptured retinal detachment
  • Anticipated need for ocular surgery during the 12-month study period
  • Any injectable, periocular, or intravitreal corticosteroid treatment to study eye within 6 months prior to screening (eg, triamcinolone acetonide)
  • Any injectable, periocular, or intravitreal anti-VEGF treatment to the study eye within 3 months prior to screening (eg, Avastin or Lucentis)
  • Any infectious condition in the study eye

Treatment and study plan

400 ug Brimonidine Implant

Drug

400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

Other names: Brimonidine Tartrate PS DDS®

200 ug Brimonidine Implant

Drug

200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.

Other names: Brimonidine Tartrate PS DDS®

Sham (no implant)

Other

Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.

Primary outcomes

  1. Percentage of Patients With at Least a 15-Letter Increase From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Month 3

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates that vision has improved. The percentage of patients with at least a 15-letter increase in BCVA in the study eye is reported.

Secondary outcomes

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye

    Time frame: Baseline, Month 3

    BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). A positive change from baseline indicates an improvement and a negative change from baseline indicates a worsening.

Other outcomes

  1. Percentage of Patients With Intraocular Pressure (IOP) < 10 mmHg in the Study Eye at Any Follow up Visit

    Time frame: 12 Months

    IOP is the fluid pressure inside the eye. The percentage of patients with IOP < 10 millimeters of mercury (mmHg) in the study eye at any follow up visit is presented.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Sep 4, 2009
Registry last updated
Apr 24, 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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