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

This study is currently recruiting participants.
Verified by Allergan, September 2008

Sponsored by: Allergan
Information provided by: Allergan
ClinicalTrials.gov Identifier: NCT00661479
  Purpose

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.


Condition Intervention Phase
Retinitis Pigmentosa
Drug: Brimonidine Tartrate
Phase I
Phase II

Genetics Home Reference related topics:   Lenz microphthalmia syndrome    oculofaciocardiodental syndrome    Peters plus syndrome    X-linked juvenile retinoschisis   

Drug Information available for:   Brimonidine    Brimonidine Tartrate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Single Blind (Subject), Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change in Visual Acuity [ Time Frame: Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Contrast sensitivity [ Time Frame: Day 1 - Month 12 ] [ Designated as safety issue: No ]
  • Patient questionnaires [ Time Frame: Day 1 - Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:   25
Study Start Date:   July 2008
Estimated Study Completion Date:   July 2010
Estimated Primary Completion Date:   January 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Group A: 100 µg Brimonidine implant in study eye and sham in fellow eye
Drug: Brimonidine Tartrate
Group A: 100 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
2: Experimental
Group B: 100 µg Brimonidine implant in study eye and sham in fellow eye
Drug: Brimonidine Tartrate
Group B: 100 µg Brimonidine Tartrate in study eye and sham in fellow eye Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
3: Experimental
Group B: 200 µg Brimonidine implant in study eye and sham in fellow eye
Drug: Brimonidine Tartrate
Group B: 200 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1
4: Experimental
Group B: 400 µg Brimonidine implant in study eye and sham in fellow eye
Drug: Brimonidine Tartrate
Group B: 400 µg Brimonidine Tartrate in study eye and sham in fellow eye using Posterior Segment Drug Delivery System (PS DDS) Applicator on Day 1

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661479

Contacts
Contact: Allergan Inc.     clinicaltrials@allergan.com    

Locations
United States, Texas
Recruiting
      Arlington, Texas, United States
France
Recruiting
      Paris, France
Germany
Recruiting
      Tubingen, Germany
Portugal
Recruiting
      Coimbra, Portugal

Sponsors and Collaborators
Allergan

Investigators
Study Director:     Medical Director     Allergan    
  More Information


Responsible Party:   Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:   190342-028D
First Received:   October 29, 2007
Last Updated:   September 26, 2008
ClinicalTrials.gov Identifier:   NCT00661479
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Pigmentary retinopathy
Genetic Diseases, Inborn
Eye Diseases
Cone rod dystrophy
Retinitis Pigmentosa
Retinitis
Retinal Degeneration
Eye Diseases, Hereditary
Retinal Diseases
Brimonidine
Retinal degeneration

Additional relevant MeSH terms:
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists

ClinicalTrials.gov processed this record on December 03, 2008




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