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The study terminated for safety reasons
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| Name | Class |
|---|---|
| PPD Development, LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT-0814 High dose | Experimental |
| |
| MT-0814 Low dose | Experimental | MT-0814 plus placebo |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT-0814 | Drug | Randomly assigned dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Senju Investigational Site | Peoria | Arizona | 85381 | United States | ||
| Senju Investigational Site |
Not provided
| Label | URL |
|---|---|
| FDA Safety Alerts and Recalls | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo: Placebo manufactured to mimic MT-0814 |
| FG001 | MT-0814 Low Dose | MT-0814 plus placebo MT-0814: Randomly assigned dose Placebo: Placebo manufactured to mimic MT-0814 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2019 |
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| Placebo |
| Drug |
Placebo manufactured to mimic MT-0814 |
|
| Baseline and Week 12 |
| Phoenix |
| Arizona |
| 85053 |
| United States |
| Senju Investigational Site | Pasadena | California | 91107 | United States |
| Senju Investigational Site | Redlands | California | 92374 | United States |
| Senju Investigational Site | Altamonte Springs | Florida | 32701 | United States |
| Senju Investigational Site | Clearwater | Florida | 33761 | United States |
| Senju Investigational Site | Melbourne | Florida | 32901 | United States |
| Senju Investigational Site | Tallahassee | Florida | 32308 | United States |
| Senju Investigational Site | Arlington | Texas | 76012 | United States |
| Senju Investigational Site | Houston | Texas | 77030 | United States |
| Senju Investigational Site | San Antonio | Texas | 78240 | United States |
| Senju Investigational Site | The Woodlands | Texas | 77384 | United States |
| Senju Investigational Site | Murray | Utah | 84107 | United States |
| FG002 | MT-0814 High Dose | MT-0814: Randomly assigned dose |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo: Placebo manufactured to mimic MT-0814 |
| BG001 | MT-0814 Low Dose | MT-0814 plus placebo MT-0814: Randomly assigned dose Placebo: Placebo manufactured to mimic MT-0814 |
| BG002 | MT-0814 High Dose | MT-0814: Randomly assigned dose |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Best-corrected Visual Acuity (BCVA) : Study eye | 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. | Mean | Standard Deviation | Letters |
| ||||||||||||||
| Central Subfield Thickness (CSFT) : Study eye | Mean | Standard Deviation | mm |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Full-analysis set (FAS): The FAS consisted of all participants who were randomly assigned to receive double-masked study drug and who have received at least 1 dose of study drug. All analyses using the FAS grouped participants according to randomly assigned treatment. | Posted | Least Squares Mean | 95% Confidence Interval | letters | Baseline and Week 12 |
|
|
| |||||||||||||||||||||||||||||||
| Secondary | 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-analysis set (FAS): The FAS consisted of all participants who were randomly assigned to receive double-masked study drug and who have received at least 1 dose of study drug. All analyses using the FAS grouped participants according to randomly assigned treatment. | Posted | Least Squares Mean | 95% Confidence Interval | mm | Baseline and Week 12 |
|
16 weeks
Adverse events were analyzed in terms of Treatment-Emergent Adverse Events (TEAEs), which were defined as any event not present before exposure to study drug or any event already present that worsened in either intensity or frequency after exposure to the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo: Placebo manufactured to mimic MT-0814 | 0 | 3 | 0 | 3 | 3 | 3 |
| EG001 | MT-0814 Low Dose | MT-0814 plus placebo MT-0814: Randomly assigned dose Placebo: Placebo manufactured to mimic MT-0814 | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | MT-0814 High Dose | MT-0814: Randomly assigned dose | 0 | 5 | 2 | 5 | 3 | 5 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic enzyme increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA version 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Migraine | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Neovascular age-related macular degneration | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Subretinal fluid | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Faeces discoloured | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Mitral valve prolapse | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| Dry age-related macular degeneration | Eye disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
| |
| Tension headach | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 23.0 | Systematic Assessment |
| |
| High density lipoprotein decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Development | Senju Pharmaceutical Co. Ltd. | +81 078 777 1018 | senju-clinicaltrials@senju.co.jp |
| Feb 24, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Whte |
|
| Other |
|
| Units | Counts |
|---|---|
| Participants |
|
|