Punctate Inner ChoroidopathyNCT03897192
Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis
An observational study of Punctate Inner Choroidopathy, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
To report the long term prognosis in patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR). Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Punctate Inner Choroidopathy
- What is being tested?
- Bevacizumab
- How many people
- 14 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2018to 20 Mar 2019
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: We included patients of PIC/MFC and ZOR with a clinical follow up of 4 years or longer. Patients were recorded of age, sex, best corrected visual acuity (BCVA), refractive status, coexistence of choroidal neovascularization, number and total area of PIC/MFC lesions, treatment, and recurrent activity.
Who may be able to join
- Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
- Follow up over 4 years.
Who cannot join
- Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) without zonal outer retinopathy (ZOR).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor
To report the long term prognosis in patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
- Conditions
- Punctate Inner Choroidopathy
- Being tested
- Bevacizumab
- Keywords
- punctate inner choroidopathy, multifocal choroiditis, zonal outer retinopathy, long-term outcome
- Medical subject headings
- White Dot Syndromes, Multifocal Choroiditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Anti-vascular endothelial growth factor (VEGF)
What is being measured
The primary outcome is the main question the study is designed to answer.
Wilcoxon Signed-Rank test
A statistical comparison of average of different time point
Measured: Baseline, 4 year
Secondary outcomes (1)
visual acuity
visual acuity change in logMAR in different time point
Measured: Baseline, 6 month, 12 month, 24 month, 36 month, 48 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2019
- Study start1 Oct 2018
- Primary completion31 Jan 2019
- Study completion20 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Punctate Inner ChoroidopathyStudies 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San Ni Chen, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03897192
- Sponsor's protocol ID
- 190318
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 1 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor
- ClinicalTrials.gov ID
- NCT03897192
- Acronym / sponsor ID
- 190318
- Conditions
- Punctate Inner Choroidopathy
- Keywords
- punctate inner choroidopathy, multifocal choroiditis, zonal outer retinopathy, long-term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 20 Mar 2019 (actual)
- First posted
- 1 Apr 2019 (actual)
- 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 report the long term prognosis in patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- We included patients of PIC/MFC and ZOR with a clinical follow up of 4 years or longer. Patients were recorded of age, sex, best corrected visual acuity (BCVA), refractive status, coexistence of choroidal neovascularization, number and total area of PIC/MFC lesions, treatment, and recurrent activity.
Key inclusion criteria (2 listed)
- Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
- Follow up over 4 years.
Key exclusion criteria (1 listed)
- Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) without zonal outer retinopathy (ZOR).
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 |
|---|---|---|
| BevacizumabAnti-vascular endothelial growth factor (VEGF) | Drug | – |
Primary outcome
Wilcoxon Signed-Rank test
Time frame: Baseline, 4 year
A statistical comparison of average of different time point
1 secondary outcome
visual acuity
Time frame: Baseline, 6 month, 12 month, 24 month, 36 month, 48 month
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 1 Apr 2019.
- Individual participant dataSharing planned: Undecided
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 Punctate Inner Choroidopathy, run by Changhua Christian Hospital at 1 site in Taiwan.
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 1 Apr 2019. 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 Taiwan. 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?
Wilcoxon Signed-Rank test (time frame: Baseline, 4 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 1 Apr 2019.