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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Age-related Macular Degeneration

Intervention / Treatment
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* Drug: MT-0814
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | Baseline and Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exudative, Wet, AMD, Age-related macular degeneration, Age related macular degeneration