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

• Status: Terminated
• Trial end date: 2020-04-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Senju Pharmaceutical Co., Ltd.
• Collaborator: PPD

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.