Age-related Macular Degeneration
Conditions
Keywords
Exudative, Wet, AMD, Age-related macular degeneration, Age related macular degeneration
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.
Interventions
DRUGMT-0814
Randomly assigned dose
DRUGPlacebo
Placebo manufactured to mimic MT-0814
Sponsors
PPD Development, LP
Senju Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best-corrected Visual Acuity (BCVA) : Study Eye | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Central Subfield Thickness (CSFT) : Study Eye | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo: Placebo manufactured to mimic MT-0814 | 3 |
| MT-0814 Low Dose MT-0814 plus placebo
MT-0814: Randomly assigned dose
Placebo: Placebo manufactured to mimic MT-0814 | 5 |
| MT-0814 High Dose MT-0814: Randomly assigned dose | 5 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 3 | 1 |
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Study prematurely terminated by sponsor | 0 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | MT-0814 Low Dose | MT-0814 High Dose | Placebo | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 5 Participants | 1 Participants | 10 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 2 Participants | 3 Participants |
| Best-corrected Visual Acuity (BCVA) : Study eye | 66.8 Letters STANDARD_DEVIATION 7.98 | 71.2 Letters STANDARD_DEVIATION 4.15 | 62.0 Letters STANDARD_DEVIATION 10.82 | 67.4 Letters STANDARD_DEVIATION 7.74 |
| Central Subfield Thickness (CSFT) : Study eye | 0.3748 mm STANDARD_DEVIATION 0.05981 | 0.3954 mm STANDARD_DEVIATION 0.08581 | 0.2990 mm STANDARD_DEVIATION 0.04015 | 0.3652 mm STANDARD_DEVIATION 0.07369 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Whte | 5 Participants | 5 Participants | 3 Participants | 13 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 3 participants | 13 participants |
| Sex: Female, Male Female | 4 Participants | 2 Participants | 2 Participants | 8 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 1 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 5 | 0 / 5 |
| other Total, other adverse events | 3 / 3 | 5 / 5 | 3 / 5 |
| serious Total, serious adverse events | 0 / 3 | 0 / 5 | 2 / 5 |
Outcome results
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change in Best-corrected Visual Acuity (BCVA) : Study Eye | 0.4 letters |
| MT-0814 Low Dose | Change in Best-corrected Visual Acuity (BCVA) : Study Eye | 0.3 letters |
| MT-0814 High Dose | Change in Best-corrected Visual Acuity (BCVA) : Study Eye | 0.1 letters |
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.
Time frame: Baseline and Week 12
Population: 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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Placebo | Change in Central Subfield Thickness (CSFT) : Study Eye | -0.0053 mm |
| MT-0814 Low Dose | Change in Central Subfield Thickness (CSFT) : Study Eye | -0.0016 mm |
| MT-0814 High Dose | Change in Central Subfield Thickness (CSFT) : Study Eye | 0.0026 mm |