Clinical trial NCT03869684: A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
Official title: A Double-Masked, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of MT-0814 for the Treatment of Patients With Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-related Macular Degeneration
Keywords: Exudative
Wet
AMD
Age-related macular degeneration
Age related macular degeneration
Lead sponsor: Senju Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: PPD Development, LP
First posted: 2019-03-11
Enrollment: 13
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Change in Best-corrected Visual Acuity (BCVA) : Study Eye
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change in Central Subfield Thickness (CSFT) : Study Eye
timeFrame: Baseline and Week 12
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Senju Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Senju Investigational Site
state: Arizona
city: Pasadena
country: United States
facility: Senju Investigational Site
state: California
city: Redlands
country: United States
facility: Senju Investigational Site
state: California
city: Altamonte Springs
country: United States
facility: Senju Investigational Site
state: Florida
city: Clearwater
country: United States
facility: Senju Investigational Site
state: Florida
city: Melbourne
country: United States
facility: Senju Investigational Site
state: Florida
city: Tallahassee
country: United States
facility: Senju Investigational Site
state: Florida
city: Arlington
country: United States
facility: Senju Investigational Site
state: Texas
city: Houston
country: United States
facility: Senju Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Senju Investigational Site
state: Texas
city: The Woodlands
country: United States
facility: Senju Investigational Site
state: Texas
city: Murray
country: United States
facility: Senju Investigational Site
state: Utah
Study officials:
References: