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

Senju Pharmaceutical

Status and phase: Terminated; Phase 2

Conditions: Age-related Macular Degeneration

Treatments: Drug: MT-0814; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03869684

MT-0814/2-01

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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13 participants in 3 patient groups, including a placebo group

MT-0814 High dose

Experimental group

Treatment:

Drug: MT-0814

MT-0814 Low dose

Experimental group

Description:

MT-0814 plus placebo

Treatment:

Drug: MT-0814

Drug: Placebo

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo