Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)

Macular Degeneration Clinical Trial

Official title:

Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00658619
• Other study ID #: 190342-032D
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2008
• Est. completion date: April 8, 2011

Study information

• Verified date: July 2018
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Stage 1 is a patient-masked, dose-escalation, safety evaluation of brimonidine intravitreal implant. Patients will receive implant in one eye and "sham" treatment (meaning no treatment) in the fellow eye. Stage 2 will begin after 1 month of safety has been evaluated for Stage 1. Stage 2 is a randomized, double-masked, dose-response, sham-controlled evaluation of the safety and efficacy of brimonidine intravitreal implant in patients with geographic atrophy from age-related macular degeneration. Patients will be followed for up to 2 years.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: April 8, 2011
• Est. primary completion date: June 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Geographic atrophy in both eyes due to age-related macular degeneration

• Visual acuity between 20/40 to 20/320

Exclusion Criteria:

• Known allergy to brimonidine

• Uncontrolled systemic disease or infection of the eye

• Recent eye surgery or injections in the eye

• Female patients who are pregnant, nursing or planning a pregnancy

Related Conditions & MeSH terms

• Atrophy
• Geographic Atrophy
• Macular Degeneration

Intervention

Drug:
• 400 µg Brimonidine Tartrate Implant
400 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.
• 200 µg Brimonidine Tartrate Implant
200 µg brimonidine tartrate implant in the study eye on Day 1 and Month 6.

Other:
• Sham (no implant)
Sham in one or both eyes on Day 1 and Month 6.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  Germany,  Italy,  Korea, Republic of,  Philippines,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye	Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).	Baseline, Month 12
Secondary	Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye	Change from baseline in size of geographic atrophy lesion area in the study eye is based on fundus photography as read by an independent Reading Center. Photographs are taken with a specialized microscope with an attached camera to photograph the interior of the eye, including the retina and optic disc. A positive change from baseline indicates an increase in size of geographic atrophy lesion area (worsening; disease progression). Data are reported in disc area where 1 disc area = 1.767 millimeters squared (mm^2).	Baseline, Month 3, Month 6, Month 9, Month 18, Month 24
Secondary	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, 24 Months
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, 24 Months
Secondary	Change From Baseline in Reading Speed in the Study Eye	Change from baseline in reading speed in the study eye is assessed using modified Bailey-Lovie word charts. Patients read the chart for 2 minutes and the numbers of words read correctly per minute are totaled. An increase in the number of words read correctly indicates an improvement and a decrease in the number of words read correctly indicates a worsening.	Baseline, 24 Months