Diabetic RetinopathyNCT02026843
Analysis of Biomarkers From Patients With Chorioretinal Diseases
An observational study of Diabetic Retinopathy and Macular Degeneration, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to investigate the levels of ocular biomarkers from the patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Macular Degeneration
- What is being tested?
- Chorioretinal diseases
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Apr 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 100 patients will be included. 50 patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. and 50 control patients scheduled for pars plana vitrectomy for nondiabetic retinal disease or phacoemulsification.
Who may be able to join
- age over 20 years
- patients requiring ophthalmologic treatments for different degrees of decreasing of visual acuity.
- patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration.
- control patients asking cataract surgery or vitrectomy for posterior segment nonproliferative disorders.
Who cannot join
- under the age of 20 years
- patients that received any anti-vascular endothelial growth factor agent for proliferative disease before taking sample of aqueous humor
- patients that did not signed the informed consent of the trial
- patients with intraocular inflammations or infections that requiring any pharmaceutical agent
- patients with recent ocular trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Dong Ho Park
Daegu, Kyungsangpookdo, 700-721
Dong Ho Park, M.D, 82-53-420-5813, sarasate2222@gmail.com
About this study
This study was conducted to investigate the levels of ocular biomarkers from the patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration.
Read the detailed description
This prospective, case-control study included 50 patients(50eyes) with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. and 50 patient with nondiabetic retinopathy or cataract. Ocular fluids and blood samples were taken before injection of anti-vascular endothelial growth factor agent or pars plana vitrectomy for other retinal disease. Ocular biomarkers were analyzed.
- Conditions
- Diabetic Retinopathy, Macular Degeneration
- Being tested
- Chorioretinal diseases
- Medical subject headings
- Diabetic Retinopathy, Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chorioretinal diseasesDrug
chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration
| Study group | Role | What they receive |
|---|---|---|
| Chorioretinal diseases | chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. Receives: Drug: Chorioretinal diseases | |
| Control | control patients with surgeries include pars plana vitrectomy of macular hole, epiretinal membrane, cataract surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers in ocular fluids
To establish if certain type of chorioretinal diseases group are associated to different concentrations of gene or protein concentration.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startApr 2012
- Primary completionFeb 2028 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Ho Park, Kyungpook National University Hospital
- Investigators
- Dong Ho Park, M.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026843
- Sponsor's protocol ID
- KNUH2013-1
- Status last verified
- Mar 2025
- First submitted
- 29 Dec 2013
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Biomarkers From Patients With Chorioretinal Diseases
- ClinicalTrials.gov ID
- NCT02026843
- Acronym / sponsor ID
- KNUH2013-1
- Conditions
- Diabetic Retinopathy, Macular Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 3 Jan 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.
This study was conducted to investigate the levels of ocular biomarkers from the patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration.
Detailed description
This prospective, case-control study included 50 patients(50eyes) with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. and 50 patient with nondiabetic retinopathy or cataract. Ocular fluids and blood samples were taken before injection of anti-vascular endothelial growth factor agent or pars plana vitrectomy for other retinal disease. Ocular biomarkers were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chorioretinal diseases | – | Drug: Chorioretinal diseaseschorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. |
| Control | – | –control patients with surgeries include pars plana vitrectomy of macular hole, epiretinal membrane, cataract surgery. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 100 patients will be included. 50 patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration. and 50 control patients scheduled for pars plana vitrectomy for nondiabetic retinal disease or phacoemulsification.
Key inclusion criteria (4 listed)
- age over 20 years
- patients requiring ophthalmologic treatments for different degrees of decreasing of visual acuity.
- patients with chorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration.
- control patients asking cataract surgery or vitrectomy for posterior segment nonproliferative disorders.
Key exclusion criteria (5 listed)
- under the age of 20 years
- patients that received any anti-vascular endothelial growth factor agent for proliferative disease before taking sample of aqueous humor
- patients that did not signed the informed consent of the trial
- patients with intraocular inflammations or infections that requiring any pharmaceutical agent
- patients with recent ocular trauma
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 |
|---|---|---|
| Chorioretinal diseaseschorioretinal diseases including diabetic retinopathy, retinal vascular diseases, age-related macular degeneration (dry and wet), and retinal degeneration | Drug | Chorioretinal diseases |
Primary outcome
Biomarkers in ocular fluids
Time frame: one month
To establish if certain type of chorioretinal diseases group are associated to different concentrations of gene or protein concentration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Diabetic Retinopathy
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
Proliferative Diabetic Retinopathy (PDR)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
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.
Dong Ho Park, M.D principal investigator
Kyungpook National University Hospital
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 Diabetic Retinopathy and Macular Degeneration, run by Kyungpook National University Hospital at 1 site in South Korea.
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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Mar 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dong Ho Park, M.D. (82-53-420-5813, sarasate2222@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers in ocular fluids (time frame: one 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 6 Mar 2025.