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

Age-related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03869684
• Other study ID #: MT-0814/2-01
• Status: Terminated
• Phase: Phase 2
• Start date: February 25, 2019
• Est. completion date: April 24, 2020

Study information

• Verified date: March 2021
• Source: Senju Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: April 24, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• MT-0814
Randomly assigned dose
• Placebo
Placebo manufactured to mimic MT-0814

Locations

Country	Name	City	State
United States	Senju Investigational Site	Altamonte Springs	Florida
United States	Senju Investigational Site	Arlington	Texas
United States	Senju Investigational Site	Clearwater	Florida
United States	Senju Investigational Site	Houston	Texas
United States	Senju Investigational Site	Melbourne	Florida
United States	Senju Investigational Site	Murray	Utah
United States	Senju Investigational Site	Pasadena	California
United States	Senju Investigational Site	Peoria	Arizona
United States	Senju Investigational Site	Phoenix	Arizona
United States	Senju Investigational Site	Redlands	California
United States	Senju Investigational Site	San Antonio	Texas
United States	Senju Investigational Site	Tallahassee	Florida
United States	Senju Investigational Site	The Woodlands	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Senju Pharmaceutical Co., Ltd.	PPD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	Baseline and Week 12

External Links

•   FDA Safety Alerts and Recalls