Biomarkers of Diabetic RetinopathyNCT06269419
Study of Natural Course Progression of Diabetic Retinopathy
An observational study of Biomarkers of Diabetic Retinopathy, run by Jie Li at 1 site in China.
Trial summary
The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biomarkers of Diabetic Retinopathy
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 25 Feb 2024to 1 Jan 2029
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.
Who may be able to join
- Patients with type 2 diabetes aged 18-75 years
- Can cooperate with the inspection and sign the informed consent
- There are no other eye diseases that cause retinal neovascularization
- There is no known substantial media haze that would hinder fundus image acquisition
- No history of fundus laser treatment or no possibility of laser treatment expected within six months
- No previous history of intravitreal drug injection, and no intravitreal drug injection is expected in the next 6 months
Show all 9Show fewer
- Macular edema without diabetes (Zeiss OCT women < 290µm, male < 305µm; OCT female in Heidelberg is < 305µm, and for males < 320µm)
- In the field of visual field of clinical mydriasis and Optos photo 7 field of view, DR Lesions were less severe than NPDR
- No history of eye surgery
Who cannot join
- Patients with kidney failure.
- History of systemic anti-VEGF therapy within the last month.
- Follow-up is expected to be difficult or patients from other provinces have traction retinal detachment;
- The patient has a history of allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Academy of Medical Science Sichuan Provincial Hosptial
Chengdu, Sichuan, 610014
Jie Li, doctor, +86 13908094675, lijieyk@med.uestc.edu.cn
About this study
Official title: Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy
The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.
Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.
Read more
The contents of follow-up examinations are:
History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.
Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).
Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.
Urinary microalbumin/urinary creatinine ACR. Microvisual field.
- Conditions
- Biomarkers of Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes patients with no diabetic retinopathy | Not described | |
| Type 2 diabetes patients with mild to moderate diabetic non-proliferative retinopathy | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation and follow-up of biomarkers of diabetic retinopathy
The biomarkers of diabetic retinopathy were observed by eye examinations including best corrected visual acuity, logarithmic visual acuity chart, TupaOCTA 24×20mm, 6×6mm scan, Optos fundus color and non-red light images, microvisual field at each follow-up.
Measured: 2024-2029
Level of Glycosylated hemoglobin
tested by venous blood
Measured: 2024-2029
Creatinine
tested by venous blood
Measured: 2024-2029
Total cholesterol
tested by venous blood
Measured: 2024-2029
Urinary microalbumin
tested by urine
Measured: 2024-2029
Urea
tested by venous blood
Measured: 2024-2029
Glomerular filtration rate
tested by venous blood
Measured: 2024-2029
Triglycerides
tested by venous blood
Measured: 2024-2029
Low-density lipoprotein cholesterol
tested by venous blood
Measured: 2024-2029
High-density lipoprotein cholesterol
tested by venous blood
Measured: 2024-2029
Urinary creatinine ACR
tested by urine
Measured: 2024-2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start25 Feb 2024
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomarkers of 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Li, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269419
- Sponsor's protocol ID
- 2023-KY295
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 12 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 2030, via https://pan.baidu.com
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Natural Course Progression of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06269419
- Acronym / sponsor ID
- 2023-KY295
- Conditions
- Biomarkers of Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jie LiUniversity, hospital or other
- Study start
- 25 Feb 2024 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 21 Feb 2024 (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.
The goal of this observational study is to observe the formation and development of the non-perfusion area of diabetic retinopathy in the posterior area of the retina in type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.The main questions it aims to answer are whether posterior retinal non-perfusion area occurs earlier than peripheral non-perfusion area and whether the rate of non-perfusion area expansion is a risk factor for the progression of diabetic retinopathy.
Participants will have protocol-specific follow-up examinations at 1, 2, 3, 4, and 5 years (± 3 months). Additional visits are made as required by the study and the patient's condition.
The contents of follow-up examinations are:
History of other diseases, medications being used, eye diseases, surgeries, treatments, height, weight, and blood pressure.
Best corrected vision, logarithmic visual acuity chart. Tupai OCTA, 24×20mm range, 6×6mm range scan. Optos fundus imaging, color and no red light images. Fundus fluorescence angiography (only preliminary examination for the first time found mild to moderate NPDR patients, who have been angiographed in the past, only at the 5th year, or as required by the condition).
Glycosylated hemoglobin. Creatinine, urea, glomerular filtration rate. Total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol.
Urinary microalbumin/urinary creatinine ACR. Microvisual field.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes patients with no diabetic retinopathy | – | – |
| Type 2 diabetes patients with mild to moderate diabetic non-proliferative retinopathy | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 diabetes patients aged 18-75 years old, who can cooperate with all examinations and sign informed consent, clinical myopathy examination and Optos 7 field of vision with mild than severe NPDR, and no other exclusion indicators.
Key inclusion criteria (9 listed)
- Patients with type 2 diabetes aged 18-75 years
- Can cooperate with the inspection and sign the informed consent
- There are no other eye diseases that cause retinal neovascularization
- There is no known substantial media haze that would hinder fundus image acquisition
- No history of fundus laser treatment or no possibility of laser treatment expected within six months
Key exclusion criteria (4 listed)
- Patients with kidney failure.
- History of systemic anti-VEGF therapy within the last month.
- Follow-up is expected to be difficult or patients from other provinces have traction retinal detachment;
- The patient has a history of allergy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Observation and follow-up of biomarkers of diabetic retinopathy
Time frame: 2024-2029
The biomarkers of diabetic retinopathy were observed by eye examinations including best corrected visual acuity, logarithmic visual acuity chart, TupaOCTA 24×20mm, 6×6mm scan, Optos fundus color and non-red light images, microvisual field at each follow-up.
Level of Glycosylated hemoglobin
Time frame: 2024-2029
tested by venous blood
Creatinine
Time frame: 2024-2029
tested by venous blood
Total cholesterol
Time frame: 2024-2029
tested by venous blood
Urinary microalbumin
Time frame: 2024-2029
tested by urine
Urea
Time frame: 2024-2029
tested by venous blood
Glomerular filtration rate
Time frame: 2024-2029
tested by venous blood
Triglycerides
Time frame: 2024-2029
tested by venous blood
Low-density lipoprotein cholesterol
Time frame: 2024-2029
tested by venous blood
High-density lipoprotein cholesterol
Time frame: 2024-2029
tested by venous blood
Urinary creatinine ACR
Time frame: 2024-2029
tested by urine
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 12 Mar 2024.
- Individual participant dataSharing planned: Yes. 2030, via https://pan.baidu.com
Related trials for Biomarkers of Diabetic Retinopathy
RecruitingObservational study
Longitudinal Observational Study of Diabetic Retinopathy Progression in Type 2 Diabetes Patients
Diabetic Retinopathy, Diabetes Mellitus, Type 2
RecruitingObservational study
Biomarker of Diabetic Retinopathy
Diabetic Retinopathy
Recruiting
Proteomic Biomarker Identification in Age-Related Macular Degeneration, Diabetic Retinopathy and Retinal Detachment
Age-Related Macular Degeneration (AMD), Diabetic Retinopathy (DR)
Recruiting
Biomarkers in Diabetic Retinopathy Treated With Faricimab vs Biosimilar Ranibizumab
Diabetic Retinopathy (DR), Diabetic Macular Edema (DME)
Active, not recruitingObservational study
The Potential of Optical Coherence Tomography Angiography (OCTA) to Detect Early Cognitive Dysfunction in Diabetic Patients
Type 2 Diabetes Mellitus Diabetic Retinopathy Cognitive Dysfunction
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.
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 Biomarkers of Diabetic Retinopathy, run by Jie Li at 1 site in China.
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 9 inclusion and 4 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 12 Mar 2024. 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 China. 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 Jie Li, doctor (+86 13908094675, lijieyk@med.uestc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observation and follow-up of biomarkers of diabetic retinopathy (time frame: 2024-2029). The study lists 11 primary outcomes in all. 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 12 Mar 2024.