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A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration

Information source: Allergan
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Geographic Atrophy; Macular Degeneration

Intervention: 400 µg Brimonidine Implant (Drug); Sham (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: Allergan

Official(s) and/or principal investigator(s):
Medical Director, Study Director, Affiliation: Allergan

Overall contact:
Allergan Inc., Email: clinicaltrials@allergan.com

Summary

This study will assess the safety and efficacy of the brimonidine intravitreal implant in patients with geographic atrophy due to age-related macular degeneration.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change from Baseline in Atrophic Lesion Area in the Study Eye

Secondary outcome:

Change from Baseline in Low Luminance Best Corrected Visual Acuity (BCVA) in the Study Eye

Change from Baseline in BCVA in the Study Eye

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Geographic atrophy due to age-related macular degeneration in the study eye

- Visual acuity better than or equal to 20/80 in the study eye and 20/200 in the fellow

eye Exclusion Criteria:

- Cataract surgery or Laser-Assisted in situ Keratomileusis (LASIK) in the study eye in

the last 3 months

- Infections in either eye in the last 3 months

Locations and Contacts

Allergan Inc., Email: clinicaltrials@allergan.com

Creteil, France; Recruiting

Bonn, Germany; Recruiting

Milan, Italy; Recruiting

Frimley, United Kingdom; Recruiting

Abilene, Texas, United States; Recruiting

Arlington, Texas, United States; Recruiting

Melbourne, Victoria, Australia; Recruiting

Additional Information

More Information

Starting date: May 2014
Last updated: June 30, 2015

Page last updated: August 20, 2015

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