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

NCT00661479 | Completed Phase 1 Results DMC

• 1 other identifier: 190342-028D
• Study Type: interventional
• Target: 21
• Locations: 4 countries
• Sites: 4

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.

Conditions

Retinitis Pigmentosa

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change From Baseline in Contrast Sensitivity in the Study Eye

  Baseline, Month 6

Study Arms (4)

400 µg Brimonidine Tartrate Implant Group B

EXPERIMENTAL

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

Drug: 400 µg Brimonidine Tartrate Implant; Other: Sham (no implant)

200 µg Brimonidine Tartrate Implant Group B

EXPERIMENTAL

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

Drug: 200 µg Brimonidine Tartrate Implant; Other: Sham (no implant)

100 µg Brimonidine Tartrate Implant Group B

EXPERIMENTAL

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

Drug: 100 µg Brimonidine Tartrate Implant; Other: Sham (no implant)

100 µg Brimonidine Tartrate Implant Group A

EXPERIMENTAL

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

Drug: 100 µg Brimonidine Tartrate Implant; Other: Sham (no implant)

Interventions

400 µg Brimonidine Tartrate Implant DRUG

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

Also known as: Brimonidine Tartrate PS DDS®

400 µg Brimonidine Tartrate Implant Group B

200 µg Brimonidine Tartrate Implant DRUG

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

Also known as: Brimonidine Tartrate PS DDS®

200 µg Brimonidine Tartrate Implant Group B

100 µg Brimonidine Tartrate Implant DRUG

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

Also known as: Brimonidine Tartrate PS DDS®

100 µg Brimonidine Tartrate Implant Group A; 100 µg Brimonidine Tartrate Implant Group B

Sham (no implant) OTHER

Sham in the fellow eye on Day 1.

100 µg Brimonidine Tartrate Implant Group A; 100 µg Brimonidine Tartrate Implant Group B; 200 µg Brimonidine Tartrate Implant Group B; 400 µg Brimonidine Tartrate Implant Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Retinitis Pigmentosa in both eyes
• Visual acuity between 20/40 to count fingers

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (4)

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Tübingen, Germany

Location

Unknown Facility

Coimbra, Portugal

Location

MeSH Terms

Conditions

Retinitis Pigmentosa

Interventions

Brimonidine Tartrate; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2007
• First Posted: April 18, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: May 1, 2010
• Last Updated: April 24, 2013
• Results First Posted: April 24, 2013

Record last verified: 2013-03

Locations

US (1); DE (1); PT (1); FR (1)