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

Overview

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-vasoendothelial 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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 2020

Interventions

  • Drug: MT-0814
    • Randomly assigned dose
  • Drug: Placebo
    • Placebo manufactured to mimic MT-0814

Arms, Groups and Cohorts

  • Experimental: MT-0814 High dose
  • Experimental: MT-0814 Low dose
    • MT-0814 plus placebo
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Change in Best-corrected Visual Acuity (BCVA)
    • Time Frame: Baseline and Week 12
    • Change from Baseline in BCVA measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS)

Secondary Measures

  • Change in Central Subfield Thickness (CSFT)
    • Time Frame: Baseline and Week 12
    • Change from Baseline in CSFT, measured by Optical Coherence Tomography (OCT)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Senju Pharmaceutical Co., Ltd.
  • Collaborator
    • PPD
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • David Currin, 1-919-456-5679, David.Currin@ppdi.com

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