Genetic Polymorphism and Retinopathy of Prematurity: Correlation of Clinical Presentations and Severity
NCT ID: NCT05132257
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
500 participants
OBSERVATIONAL
2021-04-12
2024-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Evaluate the correlation between genetic polymorphism and ROP development
2. To study the possibility if there are any specific genetic polymorphisms that lead to poor outcome or recurrence of ROP after treatment.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Genomic Study of Congenital Malformation
NCT01250613
Genetic Biomarkers Associated With Child Language Development in Taiwan (II)
NCT05510570
The Role of SNP of ECM and MMP on the Development of Pathological High Myopia
NCT00172952
The Genetic Study of Primary Angle-Closure Glaucoma
NCT00155857
Verification of the Epidemiology and Mortality of Rare Diseases in Taiwan With Real-world Evidence
NCT05367115
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The preterm neonate, especially the low birth weight infant, is at a greater risk to develop disorders in multiple organ systems because of immaturity. Retinopathy of prematurity (ROP) is a disorder of the developing retina of low birth weight preterm infants that has the potential to lead to blindness. Although the pathogenesis and etiology of ROP remains unclear, many causative factors have been proposed. Vascular endothelial growth factor (VEGF) is an important regulator of angiogenesis in fetal life. In humans, polymorphisms in the VEGF gene have been reportedly associated with proliferative diabetic retinopathy and age-related degeneration. These retinal diseases might share the disease process of vasculopathy with ROP. Besides risk factors specifically associated with preterm birth, the activation of pro-inflammatory cytokines has been suggested to contribute to ROP development. Tumor necrosis factor (TNF)-α is one of the major cytokines in inflammation. Its expression was up-regulated in retinal neovascularization in animal models and proliferative eye diseases in humans. Many researchers suggest that TNF-α may affect retinal angiogenesis and predispose preterm infants for later development of ROP. Recent studies showed the possible correlation between ROP and polymorphism in VEGF (-460 T/C, +936 C/T, -634 G/C, and -2578 C/A), or TNF-α (-308 G/A). However, these studies focused on western populations. In our study, we will analyze the relationships among severity, treatment outcomes, and genetic polymorphism findings in ROP.
Study Aim and Goals
1. Evaluate the correlation between genetic polymorphism and ROP development
2. To study the possibility if there are any specific genetic polymorphisms that lead to poor outcome or recurrence of ROP after treatment.
Study Design Participants: We plan to recruit the children born at Linkou and Taipei branches of Chung Gung Memorial Hospital in 2009-2018, who are willing to undergo series of ophthalmologic examinations.
Study period: April, 2021 to March, 2024. A prospective cohort study Inclusion criteria: All children who were born at Linkou and Taipei branches of Chung Gung Memorial Hospital during the period of 2009 to 2018.
Exclusion criteria: If the parents were not willing to participate the study, or the medical records were not complete, or the follow period was less than 6 months.
Estimated patients' numbers: about 500 babies/3 years Methods: Participants will receive series of ocular exams, including: cycloplegic refractions, strabismus exams, exams of intraocular pressure, slit lamp exam, fundus exam, axial length measurement, etc. After the parent's and the participant's agreement, we will have a blood test of 3 ml and undergo DNA collection (Oragene-DNA; DNA-Genotek, Ottawa, Canada) by study personnel. We will analyze around 10 SNPs from each of candidate genes in our study.
According to patients' previous records and images, subjects will be classified as cases and controls. "Cases" will be infants with severe treatment-requiring ROP (defined as type-1 ROP \[zone I, any stage, with plus disease; zone I, stage 3, without plus disease; or zone II, stage 2 or 3, with plus disease\] or worse). "Controls" will be full-term babies without other retinal disorder, infants with no ROP or with mild ROP less severe than type-1 ROP, who are within the same birth weight group (e.g., \<1000 grams or ≥1000 grams). After matching genetic results and structural outcomes, we will analyze whether any specific genetic polymorphism had higher presentations in treatment-requiring ROP patients. Also, secondary analysis will focus on the difference between recurrent/poor outcome cases and other cases.
Statistical Analysis: Continuous variables will be analyzed with independent-t or paired-t test. One-way ANOVA will be used to compare three or more groups. Ordinal variables will be analyzed with Wilcoxon rank sum test (two independent samples) or Wilcoxon signed rank test (tow paired samples). Categorical variables will be analyzed with Chi-square test or Fisher's exact test. A multivariable logistic regression model will be constructed to assess the association between myopia prevalence and all studied risk factors. P value \<0.05 will be considered statistically significant.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PM No-ROP
Premature without retinopathy of prematurity. Prematurity was defined as birth at \< 37 weeks gestation.
No interventions assigned to this group
Mild ROP
Prematurity with mild retinopathy of prematurity. ROP not needing treatment. Prematurity was defined as birth at \< 37 weeks gestation.
No interventions assigned to this group
Severe ROP
Prematurity with type 1 retinopathy of prematurity. Prematurity was defined as birth at \< 37 weeks gestation.
Severe ROP
The treatment for ROP was either primary intravitreal injection (IVI) of anti-vascular endothelial growth factor (anti-VEGF) or laser photocoagulation or vitrectomy, and the indication for treatment was type 1 ROP, as defined by the ETROP Study.
Fullterm
Heathal fullterm.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Severe ROP
The treatment for ROP was either primary intravitreal injection (IVI) of anti-vascular endothelial growth factor (anti-VEGF) or laser photocoagulation or vitrectomy, and the indication for treatment was type 1 ROP, as defined by the ETROP Study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
2. Incomplete medical records.
3. Folllow-up period less than 6 months
4. Other ocular diagnosis including glaucoma, cataract, FEVR, etc.
3 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chang Gung Memorial Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wu WeiChi, M.D., PhD.
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Ophthalmology, Chang Gung Memorial Hospital.
Linkou District, Taoyuan, Taiwan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
202001715A3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.