Choroidal NeovascularizationNCT03793400
Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor
An observational study of Choroidal Neovascularization and Punctate Inner Choroidopathy, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Choroidal Neovascularization, Punctate Inner Choroidopathy
- What is being tested?
- Bevacizumab Injection
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Mar 2018to 28 Dec 2018
- 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: The investigators included punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization patients with follow up over 4 years.
Who may be able to join
- Patients were punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization.
- Follow up over 4 years.
Who cannot join
- Patients were not punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization
- Patients were punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization but loss follow over 1 year.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment.
Read the detailed description
To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment.
The age, sex, best corrected visual acuity (BCVA) in Snellen chart, and refractive status for each patient were recorded. All patients had thorough clinical examinations, including slit lamp biomicroscopy, indirect ophthalmoloscopy, and spectral domain optical coherence tomography during each visit. Fundus photography, fluorescein angiography, and indocyanine angiography were performed on all patients. OCT angiography was performed.
- Being tested
- Bevacizumab Injection
- Keywords
- punctate inner choroidopathy, multifocal choroidits, choroidal neovascularization, anti-VEGF, long-term outcome
- Medical subject headings
- Choroidal Neovascularization, White Dot Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab InjectionDrug
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 two dependent samples
Measured: Baseline,48 month.
Secondary outcomes (1)
visual acuity
visual acuity in logMAR
Measured: Baseline,48 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2019
- Study start13 Mar 2018
- Primary completion13 Apr 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Choroidal NeovascularizationStudies 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
- 22 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
- NCT03793400
- Sponsor's protocol ID
- 180916
- Status last verified
- Jan 2019
- First submitted
- 1 Jan 2019
- Last updated
- 8 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 8 Jan 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
- NCT03793400
- Acronym / sponsor ID
- 180916
- Keywords
- punctate inner choroidopathy, multifocal choroidits, choroidal neovascularization, anti-VEGF, long-term outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 13 Mar 2018 (actual)
- Primary completion
- 13 Apr 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 4 Jan 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 evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment.
Detailed description
To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment.
The age, sex, best corrected visual acuity (BCVA) in Snellen chart, and refractive status for each patient were recorded. All patients had thorough clinical examinations, including slit lamp biomicroscopy, indirect ophthalmoloscopy, and spectral domain optical coherence tomography during each visit. Fundus photography, fluorescein angiography, and indocyanine angiography were performed on all patients. OCT angiography was performed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigators included punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization patients with follow up over 4 years.
Key inclusion criteria (2 listed)
- Patients were punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization.
- Follow up over 4 years.
Key exclusion criteria (2 listed)
- Patients were not punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization
- Patients were punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization but loss follow over 1 year.
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 |
|---|---|---|
| Bevacizumab InjectionAnti-vascular endothelial growth factor (VEGF) | Drug | – |
Primary outcome
Wilcoxon Signed-Rank test
Time frame: Baseline,48 month.
A statistical comparison of average of two dependent samples
1 secondary outcome
visual acuity
Time frame: Baseline,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 8 Jan 2019.
- Individual participant dataSharing planned: Undecided
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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 Choroidal Neovascularization and 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 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 8 Jan 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,48 month.). 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 8 Jan 2019.