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

Primary Purpose

Retinitis Pigmentosa

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
400 µg Brimonidine Tartrate Implant
200 µg Brimonidine Tartrate Implant
100 µg Brimonidine Tartrate Implant
Sham (no implant)
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retinitis Pigmentosa

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

400 µg Brimonidine Tartrate Implant Group B

200 µg Brimonidine Tartrate Implant Group B

100 µg Brimonidine Tartrate Implant Group B

100 µg Brimonidine Tartrate Implant Group A

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 29, 2007
Last Updated
March 13, 2013
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00661479
Brief Title
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinitis Pigmentosa

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
400 µg Brimonidine Tartrate Implant Group B
Arm Type
Experimental
Arm Description
400 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Arm Title
200 µg Brimonidine Tartrate Implant Group B
Arm Type
Experimental
Arm Description
200 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Arm Title
100 µg Brimonidine Tartrate Implant Group B
Arm Type
Experimental
Arm Description
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Arm Title
100 µg Brimonidine Tartrate Implant Group A
Arm Type
Experimental
Arm Description
100 µg brimonidine tartrate implant in the study eye and sham in the fellow eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
400 µg Brimonidine Tartrate Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
400 µg brimonidine tartrate implant in the study eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
200 µg Brimonidine Tartrate Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
200 µg brimonidine tartrate implant in the study eye on Day 1.
Intervention Type
Drug
Intervention Name(s)
100 µg Brimonidine Tartrate Implant
Other Intervention Name(s)
Brimonidine Tartrate PS DDS®
Intervention Description
100 µg brimonidine tartrate implant in the study eye on Day 1.
Intervention Type
Other
Intervention Name(s)
Sham (no implant)
Intervention Description
Sham in the fellow eye on Day 1.
Primary Outcome Measure Information:
Title
Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
Description
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.
Time Frame
Baseline, Month 6
Secondary Outcome Measure Information:
Title
Change From Baseline in Contrast Sensitivity in the Study Eye
Description
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.
Time Frame
Baseline, Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Arlington
State/Province
Texas
Country
United States
City
Paris
Country
France
City
Tubingen
Country
Germany
City
Coimbra
Country
Portugal

12. IPD Sharing Statement

Learn more about this trial

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

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