- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897192
Long-term Outcome of Zonal Outer Retinopathy in Punctate Inner Choroidopathy or Multifocal Choroiditis
March 28, 2019 updated by: San Ni Chen, Changhua Christian Hospital
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).
Study Overview
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Changhua, Taiwan
- Changhua Christian Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
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.
Description
Inclusion Criteria:
- Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) and associated zonal outer retinopathy (ZOR).
- Follow up over 4 years.
Exclusion Criteria:
- Patients with punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) without zonal outer retinopathy (ZOR).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Wilcoxon Signed-Rank test
Time Frame: Baseline, 4 year
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A statistical comparison of average of different time point
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Baseline, 4 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual acuity
Time Frame: Baseline, 6 month, 12 month, 24 month, 36 month, 48 month
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visual acuity change in logMAR in different time point
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Baseline, 6 month, 12 month, 24 month, 36 month, 48 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2018
Primary Completion (Actual)
January 31, 2019
Study Completion (Actual)
March 20, 2019
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
March 28, 2019
First Posted (Actual)
April 1, 2019
Study Record Updates
Last Update Posted (Actual)
April 1, 2019
Last Update Submitted That Met QC Criteria
March 28, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Panuveitis
- Uveitis
- Uveal Diseases
- Uveitis, Posterior
- Choroid Diseases
- White Dot Syndromes
- Choroiditis
- Multifocal Choroiditis
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
Other Study ID Numbers
- 190318
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.