Age-related Macular DegenerationPhase 4NCT01824225
Study of PRN and Every 2months Intravitreal Aflibercept for Age Related Macular Degeneration
A Phase 4 study testing Aflibercept in people with Age-related Macular Degeneration, run by Nihon University at 1 site in Japan.
Trial summary
Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration. 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?
- Aflibercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Mar 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Clinical diagnosis of age-related macular degeneration
Who cannot join
- Any treatment before intravitreal Aflibercept for age-related macular degeneration.
- Visual acuity above 0.1 in decimal visual acuity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration
Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.
- Conditions
- Age-related Macular Degeneration
- Being tested
- Aflibercept
- Keywords
- aflibercept, intravitreal injection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfliberceptDrug
| Study group | Role | What they receive |
|---|---|---|
| PRN injection of aflibercept | Active comparator | Intravitreal aflibercept Receives: Drug: Aflibercept |
| Two months injection of aflibercept | Active comparator | Intravitreal afilibercept Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Koji Tanaka, Nihon University
- Investigators
- Mitsuko Yuzawa, M.D., Study chair, Surugadai Nihon University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824225
- Sponsor's protocol ID
- NihonU-2
- Status last verified
- Oct 2015
- First submitted
- 31 Mar 2013
- Last updated
- 7 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of PRN and Every 2months Intravitreal Aflibercept After 3 Initial Monthly Injection for Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01824225
- Acronym / sponsor ID
- NihonU-2
- Conditions
- Age-related Macular Degeneration
- Keywords
- aflibercept, intravitreal injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate a treatment result of every two months versus as needed (PRN) after 3 initial monthly intravitreal aflibercept for the Japanese age related macular degeneration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRN injection of aflibercept | Active comparator | Drug: AfliberceptIntravitreal aflibercept |
| Two months injection of aflibercept | Active comparator | Drug: AfliberceptIntravitreal afilibercept |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of age-related macular degeneration
Key exclusion criteria (2 listed)
- Any treatment before intravitreal Aflibercept for age-related macular degeneration.
- Visual acuity above 0.1 in decimal visual acuity
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 |
|---|---|---|
| Aflibercept | Drug | PRN injection of aflibercept, Two months injection of aflibercept |
Primary outcome
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2015.
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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.
Mitsuko Yuzawa, M.D. study chair
Surugadai Nihon University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aflibercept in people with Age-related Macular Degeneration, run by Nihon University at 1 site in Japan.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 7 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual acuity after treatment by PRN or 2 months intravitreal Aflibercept (time frame: one year). 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 7 Oct 2015.