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

Primary Purpose

Age-related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MT-0814
Placebo
Sponsored by
Senju Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Exudative, Wet, AMD, Age-related macular degeneration, Age related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site
  • Senju Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

MT-0814 High dose

MT-0814 Low dose

Placebo

Arm Description

MT-0814 plus placebo

Outcomes

Primary Outcome Measures

Change in Best-corrected Visual Acuity (BCVA) : Study Eye
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.

Secondary Outcome Measures

Change in Central Subfield Thickness (CSFT) : Study Eye
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.

Full Information

First Posted
March 1, 2019
Last Updated
March 24, 2021
Sponsor
Senju Pharmaceutical Co., Ltd.
Collaborators
PPD
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1. Study Identification

Unique Protocol Identification Number
NCT03869684
Brief Title
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
The study terminated for safety reasons
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
March 25, 2020 (Actual)
Study Completion Date
April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Senju Pharmaceutical Co., Ltd.
Collaborators
PPD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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-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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Exudative, Wet, AMD, Age-related macular degeneration, Age related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-0814 High dose
Arm Type
Experimental
Arm Title
MT-0814 Low dose
Arm Type
Experimental
Arm Description
MT-0814 plus placebo
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
MT-0814
Intervention Description
Randomly assigned dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo manufactured to mimic MT-0814
Primary Outcome Measure Information:
Title
Change in Best-corrected Visual Acuity (BCVA) : Study Eye
Description
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.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Change in Central Subfield Thickness (CSFT) : Study Eye
Description
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.
Time Frame
Baseline and Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Senju Investigational Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Senju Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
Senju Investigational Site
City
Pasadena
State/Province
California
ZIP/Postal Code
91107
Country
United States
Facility Name
Senju Investigational Site
City
Redlands
State/Province
California
ZIP/Postal Code
92374
Country
United States
Facility Name
Senju Investigational Site
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Senju Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Senju Investigational Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Senju Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Senju Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Senju Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Senju Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Senju Investigational Site
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Senju Investigational Site
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.fda.gov/Safety/Recalls
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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