Age-related Macular DegenerationPhase 2NCT03869684
A Study to Assess the Safety, Tolerability and Effectiveness of MT-0814 for the Treatment of Age-related Macular Degeneration
A Phase 2 study testing MT-0814 in people with Age-related Macular Degeneration, run by Senju Pharmaceutical Co., Ltd. at 13 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- MT-0814
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 13 sitesUnited States
- Study dates
- 25 Feb 2019to 24 Apr 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Senju Investigational Site
Altamonte Springs, Florida, 32701
Senju Investigational Site
Arlington, Texas, 76012
Senju Investigational Site
Clearwater, Florida, 33761
Senju Investigational Site
Houston, Texas, 77030
Senju Investigational Site
Melbourne, Florida, 32901
Senju Investigational Site
Murray, Utah, 84107
Senju Investigational Site
Pasadena, California, 91107
Senju Investigational Site
Peoria, Arizona, 85381
Senju Investigational Site
Phoenix, Arizona, 85053
Senju Investigational Site
Redlands, California, 92374
Senju Investigational Site
San Antonio, Texas, 78240
Senju Investigational Site
Tallahassee, Florida, 32308
Senju Investigational Site
The Woodlands, Texas, 77384
About this study
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
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
- Being tested
- MT-0814, Placebo
- Keywords
- Exudative, Wet, AMD, Age-related macular degeneration, Age related macular degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MT-0814Drug
Randomly assigned dose
PlaceboDrug
Placebo manufactured to mimic MT-0814
| Study group | Role | What they receive |
|---|---|---|
| MT-0814 High dose | Experimental | Not described Receives: Drug: MT-0814 |
| MT-0814 Low dose | Experimental | MT-0814 plus placebo Receives: Drug: MT-0814; Drug: Placebo |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
Secondary outcomes (1)
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start25 Feb 2019
- Primary completion25 Mar 2020
- Study completion24 Apr 2020
Why it stopped: The study terminated for safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869684
- Sponsor's protocol ID
- MT-0814/2-01
- Status last verified
- Mar 2021
- First submitted
- 1 Mar 2019
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03869684
- Acronym / sponsor ID
- MT-0814/2-01
- Conditions
- Age-related Macular Degeneration
- Keywords
- Exudative, Wet, AMD, Age-related macular degeneration, Age related macular degeneration
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study terminated for safety reasons
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Senju Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 25 Mar 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 11 Mar 2019 (actual)
- Results
- Posted 20 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MT-0814 High dose | Experimental | Drug: MT-0814 |
| MT-0814 Low dose | Experimental | Drug: MT-0814, Drug: PlaceboMT-0814 plus placebo |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MT-0814Randomly assigned dose | Drug | MT-0814 High dose, MT-0814 Low dose |
| PlaceboPlacebo manufactured to mimic MT-0814 | Drug | MT-0814 Low dose, Placebo |
Primary outcome
Change in Best-corrected Visual Acuity (BCVA) : Study Eye
Time frame: 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.
1 secondary outcome
Change in Central Subfield Thickness (CSFT) : Study Eye
Time frame: Baseline and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MT-0814 in people with Age-related Macular Degeneration, run by Senju Pharmaceutical Co., Ltd. at 13 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Best-corrected Visual Acuity (BCVA) : Study Eye (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.