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

NCT ID: NCT00661479

Last Updated: 2013-04-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2010-05-31

Brief Summary

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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

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Conditions

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Retinitis Pigmentosa

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

400 µg Brimonidine Tartrate Implant

Intervention Type DRUG

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

Sham (no implant)

Intervention Type OTHER

Sham in the fellow eye on Day 1.

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.

Group Type EXPERIMENTAL

200 µg Brimonidine Tartrate Implant

Intervention Type DRUG

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

Sham (no implant)

Intervention Type OTHER

Sham in the fellow eye on Day 1.

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.

Group Type EXPERIMENTAL

100 µg Brimonidine Tartrate Implant

Intervention Type DRUG

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

Sham (no implant)

Intervention Type OTHER

Sham in the fellow eye on Day 1.

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.

Group Type EXPERIMENTAL

100 µg Brimonidine Tartrate Implant

Intervention Type DRUG

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

Sham (no implant)

Intervention Type OTHER

Sham in the fellow eye on Day 1.

Interventions

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400 µg Brimonidine Tartrate Implant

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

Intervention Type DRUG

200 µg Brimonidine Tartrate Implant

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

Intervention Type DRUG

100 µg Brimonidine Tartrate Implant

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

Intervention Type DRUG

Sham (no implant)

Sham in the fellow eye on Day 1.

Intervention Type OTHER

Other Intervention Names

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Brimonidine Tartrate PS DDS® Brimonidine Tartrate PS DDS® Brimonidine Tartrate PS DDS®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allergan

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Allergan

Locations

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Arlington, Texas, United States

Site Status

Paris, , France

Site Status

Tübingen, , Germany

Site Status

Coimbra, , Portugal

Site Status

Countries

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United States France Germany Portugal

Other Identifiers

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190342-028D

Identifier Type: -

Identifier Source: org_study_id

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