A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Age-related Macular Degeneration

In brief

Age-related macular degeneration (AMD) is the leading cause of blindness among adults in North America. The current standard of care for patients with exudative ("wet") AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy which must be administered by an injection into the eye every 4-8 weeks. MT-0814 is being developed for the treatment of patients with exudative AMD, and could offer an alternative, safer and less burdensome therapy.

Key facts

Study ID

NCT03869684

Run by

Senju Pharmaceutical Co., Ltd.

People needed

13

Starts

2019-02-25

Expected to finish

2020-04-24

Last updated by the study team

2021-04-20

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must agree to sign informed consent form, and to comply with protocol requirements, including study visits.
• Must have clear optic media in the study eye that is capable of producing high-quality fundus images.

You may not qualify if…

• Has active CNV due to causes other than AMD in the study eye.
• Has retinal vascular disease or retinal degeneration other than AMD in the study eye.
• Has had intraocular surgery, cataract surgery or LASIK surgery on the study eye within 90 days prior to the study.
• Has had yttrium aluminum garnet (YAG) laser capsulotomy on the study eye within 30 days prior to the study.
• Has active inflammation, infection, or other severe ocular disease in either eye.
• Has aphakia in the study eye.
• Has uncontrolled glaucoma or a history of previous glaucoma filter surgery in either eye.
• Is a contact lens wearer and is unable to discontinue their use in both eyes for the duration of the study.
• Has a serious allergy to, or experienced a prior significant adverse reaction to fluorescein angiography (FA) or indocyanine green angiography (ICGA).
• Has participated in any other clinical trial and/or has taken any investigational drug or product within 90 days prior to the study.
• Other protocol-defined inclusion/exclusion criteria could apply.

Where it is running

• Senju Investigational Site — Peoria, Arizona, United States
• Senju Investigational Site — Phoenix, Arizona, United States
• Senju Investigational Site — Pasadena, California, United States
• Senju Investigational Site — Redlands, California, United States
• Senju Investigational Site — Altamonte Springs, Florida, United States
• Senju Investigational Site — Clearwater, Florida, United States
• Senju Investigational Site — Melbourne, Florida, United States
• Senju Investigational Site — Tallahassee, Florida, United States
• Senju Investigational Site — Arlington, Texas, United States
• Senju Investigational Site — Houston, Texas, United States
• Senju Investigational Site — San Antonio, Texas, United States
• Senju Investigational Site — The Woodlands, Texas, United States
• Senju Investigational Site — Murray, Utah, United States

Full record on ClinicalTrials.gov

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