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| Name | Class |
|---|---|
| Otsuka Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACU-4429 2.5 mg | Experimental | 2.5 mg tablet |
|
| ACU-4429 5 mg | Experimental | 5 mg tablet |
|
| ACU-4429 10 mg | Experimental | 10 mg tablet |
|
| Placebo | Placebo Comparator | Includes identical tablets with only inactive ingredients (0 mg). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACU-4429 | Drug | Take orally once daily for 24 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the total area of the GA lesion(s) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in BCVA score | 24 months | |
| Frequency of AEs, discontinuations due to AEs, or dose modifications; severity and seriousness of AEs | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Acucela Medical Monitor | Kubota Vision Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States |
| 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. | |
| 29716784 | Derived |
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| 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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| Placebo | Drug | Take orally once daily for 24 months |
|
| Rosenfeld PJ, Dugel PU, Holz FG, Heier JS, Pearlman JA, Novack RL, Csaky KG, Koester JM, Gregory JK, Kubota R. Emixustat Hydrochloride for Geographic Atrophy Secondary to Age-Related Macular Degeneration: A Randomized Clinical Trial. Ophthalmology. 2018 Oct;125(10):1556-1567. doi: 10.1016/j.ophtha.2018.03.059. Epub 2018 Apr 30. |