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

NCT03869684 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: MT-0814/2-01
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 13

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.

Conditions

Age-related Macular Degeneration

Keywords

Exudative; Wet; AMD; Age-related macular degeneration; Age related macular degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  Baseline and Week 12

Study Arms (3)

MT-0814 High dose

EXPERIMENTAL

Drug: MT-0814

MT-0814 Low dose

EXPERIMENTAL

MT-0814 plus placebo

Drug: MT-0814; Drug: Placebo

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

MT-0814 DRUG

Randomly assigned dose

MT-0814 High dose; MT-0814 Low dose

Placebo DRUG

Placebo manufactured to mimic MT-0814

MT-0814 Low dose; Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Senju Pharmaceutical Co., Ltd.: lead
• PPD Development, LP: collaborator

Study Sites (13)

Senju Investigational Site

Peoria, Arizona, 85381, United States

Location

Senju Investigational Site

Phoenix, Arizona, 85053, United States

Location

Senju Investigational Site

Pasadena, California, 91107, United States

Location

Senju Investigational Site

Redlands, California, 92374, United States

Location

Senju Investigational Site

Altamonte Springs, Florida, 32701, United States

Location

Senju Investigational Site

Clearwater, Florida, 33761, United States

Location

Senju Investigational Site

Melbourne, Florida, 32901, United States

Location

Senju Investigational Site

Tallahassee, Florida, 32308, United States

Location

Senju Investigational Site

Arlington, Texas, 76012, United States

Location

Senju Investigational Site

Houston, Texas, 77030, United States

Location

Senju Investigational Site

San Antonio, Texas, 78240, United States

Location

Senju Investigational Site

The Woodlands, Texas, 77384, United States

Location

Senju Investigational Site

Murray, Utah, 84107, United States

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Limitations and Caveats

All of the efficacy and safety measurements applied in this study are widely used and generally recognized as reliable, accurate, and relevant.

Results Point of Contact

• Title: Director, Clinical Development
• Organization: Senju Pharmaceutical Co. Ltd.

senju-clinicaltrials@senju.co.jp

+81 078 777 1018

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 11, 2019
• Study Start: February 25, 2019
• Primary Completion: March 25, 2020
• Study Completion: April 24, 2020
• Last Updated: April 20, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)