The Injection BurdenNCT02126904
Comparison of the Time to Recurrence Between Ranibizumab and Aflibercept
An observational study of The Injection Burden, run by Yokohama City University Medical Center at 1 site in Japan.
Trial summary
The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- The Injection Burden
- What is being tested?
- IVA group
- How many people
- 200 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2012to Oct 2013
- Phase
- Observational
- 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
Study population: All the patients were treated at Yokohama City University Medical Center between January 2012 and October 2013.
Who may be able to join
- They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept.
Who cannot join
- patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Yokohama City University Medical Center
Yokohama, Kanagawa, 232-0024
Maiko Inoue, M.D., 81 45 261 5656 ext. 7458, maicoo@urahp.yokohama-cu.ac.jp
Maiko Inoue, M.D.
About this study
Official title: Comparison of the Time to Recurrence After Ranibizumab or Aflibercept Loading for Age-related Macular Degeneration
The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.
- Conditions
- The Injection Burden
- Being tested
- IVA group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVA groupDrug
| Study group | Role | What they receive |
|---|---|---|
| IVR group | Not described Receives: Drug: IVA group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence after induction phase
Time frame depends on patients because recurrence time is different.
Measured: More than 3 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJan 2012
- Primary completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Injection BurdenStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yokohama City University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Maiko Inoue, Yokohama City University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126904
- Sponsor's protocol ID
- 1310006
- Status last verified
- Apr 2014
- First submitted
- 27 Apr 2014
- Last updated
- 30 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Time to Recurrence After Ranibizumab or Aflibercept Loading for Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT02126904
- Acronym / sponsor ID
- 1310006
- Conditions
- The Injection Burden
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yokohama City University Medical CenterUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Oct 2013 (actual)
- First posted
- 30 Apr 2014 (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.
The investigators compared the time to recurrence after ranibizumab or aflibercept loading in patients with AMD.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IVR group | – | Drug: IVA group |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients were treated at Yokohama City University Medical Center between January 2012 and October 2013.
Key inclusion criteria (1 listed)
- They must have had BCVA better than 20/400 and had three consecutive induction treatment of ranibizumab or aflibercept.
Key exclusion criteria (1 listed)
- patients with eye diseases that could potentially influence the visual acuity of the studied eye, such as glaucoma, macular hole, diabetic retinopathy, or rhegmatogenous retinal detachment.
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 |
|---|---|---|
| IVA group | Drug | IVR group |
Primary outcome
Time to recurrence after induction phase
Time frame: More than 3 months from baseline
Time frame depends on patients because recurrence time is different.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2014.
Related trials for The Injection Burden
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Neovascular Age-related Macular Degeneration
RecruitingPhase 4
A Study to Evaluate the Impact of Pre-procedural Intracoronary Nicorandil Injection to PREVENT reductioN Of decREased TIMI FLOW in Patients Who Undergoing Percutaneous Coronary Intervention for the Coronary Artery Disease
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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.
Yokohama City University Medical Center
Yokohama, Japan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of The Injection Burden, run by Yokohama City University Medical Center 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 1 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: status not confirmed, as of the sponsor's last update on 30 Apr 2014. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence after induction phase (time frame: More than 3 months from baseline). 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 30 Apr 2014.