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

Phase 1

Completed

• Conditions: Retinitis Pigmentosa
• Interventions: Drug: 400 µg Brimonidine Tartrate Implant; Drug: 200 µg Brimonidine Tartrate Implant; Drug: 100 µg Brimonidine Tartrate Implant; Other: Sham (no implant)

• Registration Number: NCT00661479
• Lead Sponsor: Allergan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-29
• Study First Submitted QC: 2008-04-16
• Study First Posted: 2008-04-18
• Study Start: 2008-07
• Primary Completion: 2009-12
• Study Completion: 2010-05
• Disposition First Submitted: 2011-02-02
• Disposition First Submitted QC: 2011-02-02
• Disposition First Posted: 2011-02-09
• Status Verified: 2013-03
• Results First Submitted: 2013-03-13
• Results First Submitted QC: 2013-03-13
• Last Update Submitted: 2013-03-13
• Results First Posted: 2013-04-24
• Last Update Posted: 2013-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
400 µg Brimonidine Tartrate Implant Group B	400 µg Brimonidine Tartrate Implant	400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
400 µg Brimonidine Tartrate Implant Group B	Sham (no implant)	400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
200 µg Brimonidine Tartrate Implant Group B	200 µg Brimonidine Tartrate Implant	200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
200 µg Brimonidine Tartrate Implant Group B	Sham (no implant)	200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant Group B	100 µg Brimonidine Tartrate Implant	100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant Group B	Sham (no implant)	100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant Group A	100 µg Brimonidine Tartrate Implant	100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
100 µg Brimonidine Tartrate Implant Group A	Sham (no implant)	100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	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 Outcome Measures

Name	Time	Method
Change From Baseline in Contrast Sensitivity in the Study Eye	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.