Status:
TERMINATED
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
Lead Sponsor:
Senju Pharmaceutical Co., Ltd.
Collaborating Sponsors:
PPD Development, LP
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 endothelia...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2020
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03869684
Start Date
February 25 2019
End Date
April 24 2020
Last Update
April 20 2021
Active Locations (13)
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1
Senju Investigational Site
Peoria, Arizona, United States, 85381
2
Senju Investigational Site
Phoenix, Arizona, United States, 85053
3
Senju Investigational Site
Pasadena, California, United States, 91107
4
Senju Investigational Site
Redlands, California, United States, 92374