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

Retinitis Pigmentosa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661479
• Other study ID #: 190342-028D
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 29, 2007
• Last updated: March 13, 2013
• Start date: July 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2013
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinitis
• Retinitis Pigmentosa

Intervention

Drug:
• 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1.
• 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1.
• 100 µg Brimonidine Tartrate Implant
100 µg brimonidine tartrate implant in the study eye on Day 1.

Other:
• Sham (no implant)
Sham in the fellow eye on Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  France,  Germany,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No