Safety and Efficacy Assessment Treatment Trials of Emixustat Hydrochloride
NCT ID: NCT01802866
Last Updated: 2017-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
508 participants
INTERVENTIONAL
2013-02-28
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacokinetic and Pharmacodynamic Study of Emixustat in Subjects With Geographic Atrophy Associated With Dry Age-Related Macular Degeneration
NCT02130531
Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACU-4429 in Subjects With Geographic Atrophy
NCT01002950
Safety and Efficacy of Emixustat in Stargardt Disease
NCT03772665
Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease
NCT03033108
Study to Evaluate the Efficacy and Safety of Oral CT1812 in Participants With Geographic Atrophy (GA) Secondary to Dry Age-Related Macular Degeneration (AMD).
NCT05893537
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ACU-4429 2.5 mg
2.5 mg tablet
ACU-4429
Take orally once daily for 24 months
ACU-4429 5 mg
5 mg tablet
ACU-4429
Take orally once daily for 24 months
ACU-4429 10 mg
10 mg tablet
ACU-4429
Take orally once daily for 24 months
Placebo
Includes identical tablets with only inactive ingredients (0 mg).
Placebo
Take orally once daily for 24 months
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ACU-4429
Take orally once daily for 24 months
Placebo
Take orally once daily for 24 months
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Kubota Vision Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Acucela Medical Monitor
Role: STUDY_DIRECTOR
Kubota Vision Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Phoenix, Arizona, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
4429-202
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.