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.

Study Overview

• Status: Completed
• Conditions: Retinitis Pigmentosa
• Intervention / Treatment: Drug: 400 µg Brimonidine Tartrate Implant; Other: Sham (no implant); Drug: 200 µg Brimonidine Tartrate Implant; Drug: 100 µg Brimonidine Tartrate Implant

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• France
  • Paris, France
• Germany
  • Tubingen, Germany
• Portugal
  • Coimbra, Portugal
• United States
  • Texas
    • Arlington, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 400 µg Brimonidine Tartrate Implant Group B; 400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.	Drug: 400 µg Brimonidine Tartrate Implant; 400 µg brimonidine tartrate implant in the study eye on Day 1.; Other Names: Brimonidine Tartrate PS DDS®; Other: Sham (no implant); Sham in the fellow eye on Day 1.
Experimental: 200 µg Brimonidine Tartrate Implant Group B; 200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.	Other: Sham (no implant); Sham in the fellow eye on Day 1.; Drug: 200 µg Brimonidine Tartrate Implant; 200 µg brimonidine tartrate implant in the study eye on Day 1.; Other Names: Brimonidine Tartrate PS DDS®
Experimental: 100 µg Brimonidine Tartrate Implant Group B; 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.	Other: Sham (no implant); Sham in the fellow eye on Day 1.; Drug: 100 µg Brimonidine Tartrate Implant; 100 µg brimonidine tartrate implant in the study eye on Day 1.; Other Names: Brimonidine Tartrate PS DDS®
Experimental: 100 µg Brimonidine Tartrate Implant Group A; 100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.	Other: Sham (no implant); Sham in the fellow eye on Day 1.; Drug: 100 µg Brimonidine Tartrate Implant; 100 µg brimonidine tartrate implant in the study eye on Day 1.; Other Names: Brimonidine Tartrate PS DDS®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye	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.	Baseline, Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Contrast Sensitivity in the Study Eye	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.	Baseline, Month 6

Collaborators and Investigators

• Sponsor: Allergan

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: October 29, 2007
• First Submitted That Met QC Criteria: April 16, 2008
• First Posted (Estimate): April 18, 2008

Study Record Updates

• Last Update Posted (Estimate): April 24, 2013
• Last Update Submitted That Met QC Criteria: March 13, 2013
• Last Verified: March 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Retinal Dystrophies; Retinitis; Retinitis Pigmentosa; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Brimonidine Tartrate
• Other Study ID Numbers: 190342-028D

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No