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Title

A Phase 2b/3 Multicenter, Randomized, Double-Masked, Dose-Ranging Study Comparing the Efficacy and Safety of Emixustat Hydrochloride (ACU-4429) with Placebo for the Treatment of Geographic Atrophy Associated with Dry Age-Related Macular Degeneration (AMD)

MEEI Protocol ID

12-211H

National Clinical Trial (NCT) Number

NCT01802866    

Condition

Geographic atrophy (GA) secondary to AMD

Sponsor

Acucela, Inc.

Principal Investigator

Ivana Kim, MD

Study Design

This is a randomized clinical trial to compare the effectiveness of emixustat hydrochloride (ACU-4429) vs. placebo. Participants will be randomly assigned to receive one of 3 doses of ACU-4429 or placebo (inactive pill), and will take study drug by mouth once daily in the evening for 24 continuous months.

Study Objective

The objective of this study is to determine whether ACU-4429 reduces the rate of progression of geographic atrophy, compared to placebo in participants with dry age-related macular degeneration.

Who is Eligible

Men and women, age ≥ 55 years with a confirmed diagnosis of dry AMD with geographic atrophy, and best corrected visual acuity of better than approximately 20/200 in the study eye.

Patients without the following:

  • history of choroidal neovascularization or macular edema
  • other active eye disease
  • history of surgery, radiation, or transpupillary thermotherapy

Subject Enrollment

Up to twelve (12) participants will be recruited for this trial.

Study Procedures

Informed consent, physical examination, electrocardiogram (ECG), visual acuity assessment and ophthalmic exam , fundus photography, optical coherence tomography(OCT), fluorescein angiography, clinical laboratory tests, and study treatment.

For More Information, contact

Jackie Sullivan, Study Coordinator
(617) 573-3920

 

 

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Page updated 7/1/2013.