Macular DiseaseNCT02081339
Cohort Study of the Clinical Course of Macular Diseases in Japanese
An observational study of Macular Disease, run by Kyoto University, Graduate School of Medicine at 1 site in Japan.
Trial summary
Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Macular Disease
- What is being tested?
- ranibizumab, aflibercept, pegaptanib, verteporphin
- Type of treatment
- Injection or infusion
- How many people
- 1,000 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2014to Mar 2024
- How long will I take part?
- 5 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
Who may be able to join
- Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
- Patients who are agreed with the participation of this study.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Kyoto University Graduate School of Medicine
Kyoto, Kyoto, 606-8507
Misao Ogaki, +81-75-751-3248, misao@kuhp.kyoto-u.ac.jp
Akitaka Tsujikawa, MD
About this study
Official title: Cohort Study of the Clinical Course of Macular Diseases in Japanese Patients
Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth.
Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.
- Conditions
- Macular Disease
- Being tested
- ranibizumab, aflibercept, pegaptanib, verteporphin
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumab, aflibercept, pegaptanib, verteporphinDrug
| Study group | Role | What they receive |
|---|---|---|
| Macular diseases | ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡ Receives: Drug: ranibizumab, aflibercept, pegaptanib, verteporphin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial factors associated with visual prognosis in each macular disease
Measured: Five years after the registration
Secondary outcomes (1)
The difference in the visual prognosis depending on the treatments in each macular diseases
Measured: Five years after the registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2022 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DiseaseStudies 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
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Kyoto University, Graduate School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nagahisa Yoshimura, Kyoto University, Graduate School of Medicine
- Investigators
- Nagahisa Yoshimura, MD, Study chair, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081339
- Sponsor's protocol ID
- E2038
- Status last verified
- Sep 2016
- First submitted
- 22 Jan 2014
- Last updated
- 23 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study of the Clinical Course of Macular Diseases in Japanese Patients
- ClinicalTrials.gov ID
- NCT02081339
- Acronym / sponsor ID
- E2038
- Conditions
- Macular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Kyoto University, Graduate School of MedicineUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 7 Mar 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.
Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth.
Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Macular diseases | – | Drug: ranibizumab, aflibercept, pegaptanib, verteporphinranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡ |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
Key inclusion criteria (2 listed)
- Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
- Patients who are agreed with the participation of this study.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ranibizumab, aflibercept, pegaptanib, verteporphin | Drug | Macular diseases |
Primary outcome
Initial factors associated with visual prognosis in each macular disease
Time frame: Five years after the registration
1 secondary outcome
The difference in the visual prognosis depending on the treatments in each macular diseases
Time frame: Five years after the registration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2016.
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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.
Nagahisa Yoshimura, MD study chair
Kyoto University, Graduate School of Medicine
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 Macular Disease, run by Kyoto University, Graduate School of Medicine 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: status not confirmed, as of the sponsor's last update on 23 Sep 2016. 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?
Contact Akitaka Tsujikawa, MD (+81-75-751-3260, tujikawa@kuhp.kyoto-u.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial factors associated with visual prognosis in each macular disease (time frame: Five years after the registration). 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 23 Sep 2016.