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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03869684
Recruitment Status : Terminated (The study terminated for safety reasons)
First Posted : March 11, 2019
Last Update Posted : April 30, 2020
Sponsor:
Collaborator:
PPD
Information provided by (Responsible Party):
Senju Pharmaceutical Co., Ltd.

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-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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: MT-0814 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2019
Actual Primary Completion Date : March 25, 2020
Actual Study Completion Date : April 24, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

Placebo Comparator: Placebo Drug: Placebo
Placebo manufactured to mimic MT-0814




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Central Subfield Thickness (CSFT) [ Time Frame: Baseline and Week 12 ]
    Change from Baseline in CSFT, measured by Optical Coherence Tomography (OCT)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03869684


Locations
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United States, Arizona
Senju Investigational Site
Peoria, Arizona, United States, 85381
Senju Investigational Site
Phoenix, Arizona, United States, 85053
United States, California
Senju Investigational Site
Pasadena, California, United States, 91107
Senju Investigational Site
Redlands, California, United States, 92374
United States, Florida
Senju Investigational Site
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
United States, Texas
Senju Investigational Site
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
United States, Utah
Senju Investigational Site
Murray, Utah, United States, 84107
Sponsors and Collaborators
Senju Pharmaceutical Co., Ltd.
PPD
Additional Information:
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Responsible Party: Senju Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03869684    
Other Study ID Numbers: MT-0814/2-01
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Senju Pharmaceutical Co., Ltd.:
Exudative
Wet
AMD
Age-related macular degeneration
Age related macular degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases