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OpenTrials
Completed

NCT Number: NCT00661479

An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.

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Key information

Conditions

Retinitis Pigmentosa Congenital, Hereditary, and Neonatal Diseases and Abnormalities Eye Diseases Eye Diseases, Hereditary Genetic Diseases, Inborn Retinal Degeneration Retinal Diseases Retinal Dystrophies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Paris, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Retinitis Pigmentosa in both eyes
  • Visual acuity between 20/40 to count fingers

Exclusion criteria

  • Growth of new blood vessels in the eye
  • Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
  • Any ocular disease that can interfere with diagnosis and or assessment of disease progression
  • Significant near-sightedness
  • HIV
  • Female patients who are pregnant, nursing, or planning pregnancy

Treatment and study plan

400 µg Brimonidine Tartrate Implant

Drug

400 µg brimonidine tartrate implant in the study eye on Day 1.

Other names: Brimonidine Tartrate PS DDS®

200 µg Brimonidine Tartrate Implant

Drug

200 µg brimonidine tartrate implant in the study eye on Day 1.

Other names: Brimonidine Tartrate PS DDS®

100 µg Brimonidine Tartrate Implant

Drug

100 µg brimonidine tartrate implant in the study eye on Day 1.

Other names: Brimonidine Tartrate PS DDS®

Sham (no implant)

Other

Sham in the fellow eye on Day 1.

Primary outcomes

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

    Time frame: Baseline, Month 6

    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.

Secondary outcomes

  1. Change From Baseline in Contrast Sensitivity in the Study Eye

    Time frame: Baseline, Month 6

    Change from baseline in contrast sensitivity in the study eye is measured using a Pelli-Robson contrast sensitivity chart at 1 meter. The contrast sensitivity chart contains letters that are darkest at the top and then get progressively lighter. Scores range from 0 to 48 and are based on the number of letters read correctly. A negative change from baseline indicates a worsening in contrast sensitivity and a positive change from baseline indicates an improvement.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Apr 18, 2008
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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