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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug ACU-4429 in subjects with geographic atrophy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACU-4429 tablet | Experimental |
| |
| Matching placebo tablet | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACU-4429 | Drug | ACU-4429 tablets (2, 5, 7, or 10 mg) taken orally once daily for 90 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as measured by: AEs, clinical laboratory tests, vital signs, physical exams, visual tests, and questionaire | Through treatment period (up to Day 90) until 1-2 weeks post last dose (Day 97-104) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics as measured by plasma ACU-4429 drug levels | Baseline; Treatment Days 2, 7, 14, 30, 60 and 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John W Chandler, MD | Kubota Vision Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85014 | United States | ||
| Retina-Vitreous Associates Medical Group |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33331670 | Derived | Yeong JL, Loveman E, Colquitt JL, Royle P, Waugh N, Lois N. Visual cycle modulators versus placebo or observation for the prevention and treatment of geographic atrophy due to age-related macular degeneration. Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD013154. doi: 10.1002/14651858.CD013154.pub2. |
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| Matching placebo |
| Drug |
Matching placebo tablets taken orally once daily for 90 days |
|
| Beverly Hills |
| California |
| 90211 |
| United States |
| Covance Clinical Research Unit, Inc. | Daytona Beach | Florida | 32117 | United States |
| National Ophthalmic Research Institute | Fort Meyers | Florida | 33912 | United States |
| Covance Clinical Research Unit, Inc. | Honolulu | Hawaii | 96813 | United States |
| Kresege Eye Institute | Detroit | Michigan | 48201 | United States |
| Associated Retinal Consultants, P.C. / William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Covance Clinical Research Unit | Austin | Texas | 78752 | United States |
| Covance Clinical Research Unit, Inc. | Dallas | Texas | 75247 | United States |
| ID | Term |
|---|---|
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C000592692 | emixustat |
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