Polypoidal Choroidal VasculopathyNCT01271426
Response to Ranibizumab in Polypoidal Choroidal Vasculopathy (PCV)and SNPs
An observational study of Polypoidal Choroidal Vasculopathy, run by Nihon University at 1 site in Japan.
Trial summary
To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy
- How many people
- 74 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2008to Mar 2010
- 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: outpatients in hospital
Who may be able to join
- Clinical diagnosis of Polypoidal choroidal vasculopathy
- must have injection of Ranibizumab
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Japan1 site
Surugadai Nihon university hospital
1-8-13 Kandasurugadai Chiyoda-ku, Tokyo, 101-8309
About this study
Official title: Association of Complement Factor H and ARMS2 Genotypes With Response of Polypoidal Choroidal Vasculopathy to Intravitreal Ranibizumab
To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab.
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- Polypoidal Choroidal Vasculopathy, Ranibizumab
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of Complement Factor H and ARMS2 Genotypes with Response of Polypoidal Choroidal Vasuculopathy to Intravitral Ranibizumab
Measured: a month after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2011 (estimated)
- Study startApr 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal VasculopathyStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01271426
- Sponsor's protocol ID
- NihonU-1
- Status last verified
- Jan 2011
- First submitted
- 5 Jan 2011
- Last updated
- 6 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Complement Factor H and ARMS2 Genotypes With Response of Polypoidal Choroidal Vasculopathy to Intravitreal Ranibizumab
- ClinicalTrials.gov ID
- NCT01271426
- Acronym / sponsor ID
- NihonU-1
- Conditions
- Polypoidal Choroidal Vasculopathy
- Keywords
- Polypoidal Choroidal Vasculopathy, Ranibizumab
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 6 Jan 2011 (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.
To determine whether complement factor H (CFH) and age-related maculopathy susceptibility 2 (ARMS2) genotypes have a pharmacogenetic effect on the treatment of polypoidal choroidal vasculopathy (PCV) with ranibizumab.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatients in hospital
Key inclusion criteria (2 listed)
- Clinical diagnosis of Polypoidal choroidal vasculopathy
- must have injection of Ranibizumab
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Association of Complement Factor H and ARMS2 Genotypes with Response of Polypoidal Choroidal Vasuculopathy to Intravitral Ranibizumab
Time frame: a month after injection
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 6 Jan 2011.
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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.
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 Polypoidal Choroidal Vasculopathy, 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 2 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: finished, as of the sponsor's last update on 6 Jan 2011. 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?
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?
Association of Complement Factor H and ARMS2 Genotypes with Response of Polypoidal Choroidal Vasuculopathy to Intravitral Ranibizumab (time frame: a month after injection). 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 6 Jan 2011.