Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to Age-related Macular Degeneration (AMD)
Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration
Intervention: 400 µg Brimonidine Tartrate Implant (Drug); 200 µg Brimonidine Tartrate Implant (Drug); Sham (no implant) (Other)
Phase: Phase 2
Status: Completed
Sponsored by: Allergan Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan
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.
Clinical Details
Official title: Safety and Efficacy of Brimonidine Intravitreal Implant in Patients With Geographic Atrophy Due to AMD
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study Eye
Secondary outcome: Change From Baseline in Size of Geographic Atrophy Lesion Area in the Study EyeChange From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye Change From Baseline in Contrast Sensitivity in the Study Eye Change From Baseline in Reading Speed in the Study Eye
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Karlsruhe, Germany
Udine, Italy
Seoul, Korea, Republic of
Makati City, Philippines
Coimbra, Portugal
Sydney, New South Wales, Australia
Abilene, Texas, United States
Additional Information
Starting date: May 2008
Last updated: March 13, 2013
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