Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride (SEATTLE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Acucela Inc.
ClinicalTrials.gov Identifier:
NCT01802866
First received: February 28, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to determine if emixustat hydrochloride (ACU-4429) reduces the rate of progression of geographic atrophy compared to placebo in subjects with dry age-related macular degeneration.


Condition Intervention Phase
Geographic Atrophy
Drug: ACU-4429
Drug: Placebo
Phase 2
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Acucela Inc.:

Primary Outcome Measures:
  • Change from baseline in the total area of the GA lesion(s) [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in BCVA score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 480
Study Start Date: February 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ACU-4429 2.5 mg
2.5 mg tablet
Drug: ACU-4429
Take orally once daily for 24 months
Other Name: emixustat hydrochloride
Experimental: ACU-4429 5 mg
5 mg tablet
Drug: ACU-4429
Take orally once daily for 24 months
Other Name: emixustat hydrochloride
Experimental: ACU-4429 10 mg
10 mg tablet
Drug: ACU-4429
Take orally once daily for 24 months
Other Name: emixustat hydrochloride
Placebo Comparator: Placebo
Includes identical tablets with only inactive ingredients (0 mg).
Drug: Placebo
Take orally once daily for 24 months

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males or females, age ≥55 years.
  2. Clinical diagnosis of GA associated with AMD
  3. Able and willing to provide written informed consent.
  4. Able to reliably administer oral medication by self or with available assistance.

Exclusion Criteria:

  1. Active CNV or presence of an active ocular disease.
  2. Known serious allergy to the fluorescein sodium for injection in angiography.
  3. Pre-specified laboratory abnormalities at screening.
  4. Treatment with any investigational study drug within 30 days of screening or device (within 60 days of screening)
  5. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding
  6. Female subjects who are pregnant or lactating.
  7. Female subjects of childbearing potential and male subjects who are not surgically sterile who are not willing to practice a medically accepted method of birth control from screening through 30 days after completion of the study.
  8. Unstable or poorly controlled medical or ophthalmic conditions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01802866

Locations
United States, Arizona
Phoenix, Arizona, United States
Sponsors and Collaborators
Acucela Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Acucela Medical Monitor Acucela Inc.
  More Information

No publications provided

Responsible Party: Acucela Inc.
ClinicalTrials.gov Identifier: NCT01802866     History of Changes
Other Study ID Numbers: 4429-202
Study First Received: February 28, 2013
Last Updated: March 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Acucela Inc.:
Geographic atrophy
GA
Dry AMD

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 20, 2014