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

March 24, 2021 updated by: Senju Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Senju Investigational Site
      • Phoenix, Arizona, United States, 85053
        • Senju Investigational Site
    • California
      • Pasadena, California, United States, 91107
        • Senju Investigational Site
      • Redlands, California, United States, 92374
        • Senju Investigational Site
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Senju Investigational Site
      • Clearwater, Florida, United States, 33761
        • Senju Investigational Site
      • Melbourne, Florida, United States, 32901
        • Senju Investigational Site
      • Tallahassee, Florida, United States, 32308
        • Senju Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Senju Investigational Site
      • Houston, Texas, United States, 77030
        • Senju Investigational Site
      • San Antonio, Texas, United States, 78240
        • Senju Investigational Site
      • The Woodlands, Texas, United States, 77384
        • Senju Investigational Site
    • Utah
      • Murray, Utah, United States, 84107
        • Senju Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo manufactured to mimic MT-0814
Experimental: MT-0814 High dose
Drug: MT-0814
Randomly assigned dose
Experimental: MT-0814 Low dose
MT-0814 plus placebo
Drug: MT-0814
Randomly assigned dose
Drug: Placebo
Placebo manufactured to mimic MT-0814

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Best-corrected Visual Acuity (BCVA) : Study Eye
Time Frame: Baseline and Week 12

Change from Baseline in BCVA. BCVA was measured using an eye chart and is reported as number of letters read correctly using Early Treatment of Diabetic Retinopathy Study (ETDRS) Scale (0 to 100 letters) in study eye. Lower number of letters read correctly, worse the vision.

Study eye: eye that meets inclusion criteria. If both eyes meet all inclusion and exclusion criteria, the eye with the lower BCVA at Screening will be selected as the study eye. If both eyes meet all inclusion criteria and have identical BCVA at Screening, selection of the study eye will be at the investigator's discretion.
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Central Subfield Thickness (CSFT) : Study Eye
Time Frame: Baseline and Week 12

Change from Baseline in CSFT, measured by Optical Coherence Tomography (OCT).

Study eye: eye that meets inclusion criteria. If both eyes meet all inclusion and exclusion criteria, the eye with the lower BCVA at Screening will be selected as the study eye. If both eyes meet all inclusion criteria and have identical BCVA at Screening, selection of the study eye will be at the investigator's discretion.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Senju Pharmaceutical Co., Ltd.

Collaborators

PPD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2019

Primary Completion (Actual)

March 25, 2020

Study Completion (Actual)

April 24, 2020

Study Registration Dates

First Submitted

March 1, 2019

First Submitted That Met QC Criteria

March 8, 2019

First Posted (Actual)

March 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MT-0814/2-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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