Diabetic RetinopathyNCT06727955
Prospective Cohort Study on Predicting the Progression of Diabetic Microangiopathy Using Multimodal Eye Imaging
An observational study of Diabetic Retinopathy, run by Peking University Third Hospital at 1 site in China.
Trial summary
To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2028
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. age between 40 and 80 years, regardless of gender, 2. meet the diagnostic criteria of T2DM based on the Standards of Medical Care in Diabetes (2021)11, and complete evaluation at the Endocrinology Department of Peking University Third Hospital, 3. meet the Diabetic Retinopathy Severity Scale (DRSS) score level of mild to moderate-severe NPDR (i.e. 35 ≤ DRSS level ≤ 60, as shown in eTables 1 \& 2 in the Supplement) based on the montages ultra-widefield (UWF) fundus photographs,12 without clinically significant macular edema (CSME, defined as one or more of the followings: retinal thickening at or within 500 μm of the center of the macula; hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; or a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula),13 4. willing to sign the informed consent form.
Who may be able to join
- (1) age between 40 and 80 years, regardless of gender, (2) meet the diagnostic criteria of T2DM based on the Standards of Medical Care in Diabetes (2021)11, and complete evaluation at the Endocrinology Department of Peking University Third Hospital, (3) meet the Diabetic Retinopathy Severity Scale (DRSS) score level of mild to moderate-severe NPDR (i.e. 35 ≤ DRSS level ≤ 60, as shown in eTables 1 \& 2 in the Supplement) based on the montages ultra-widefield (UWF) fundus photographs,12 without clinically significant macular edema (CSME, defined as one or more of the followings: retinal thickening at or within 500 μm of the center of the macula; hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; or a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula),13 (4) willing to sign the informed consent form.
Who cannot join
- (1) conjunctivitis, keratitis, blepharitis, episcleritis, scleritis, uveitis, severe dry eye disease, using anti-glaucoma eyedrops, or any condition causing conjunctival congestion or ciliary congestion, (2) pterygium, wearing contact lens in the past week, ocular surface burn, conjunctival tumors, or any condition causing significant conjunctival vascular deformities, (3) previously undergone intraocular surgeries involving manipulation of the conjunctiva, or corneal refractive surgery, (4) history of hematological disorder, dysthyroidism, rheumatic disorder, malignant tumor, (5) refractive media opacity resulting in poor visualization of fundus photographs, (6) difficulty in maintaining fixation or comprehension, making it challenging to cooperate with the examination, (7) difficulty in completing follow-up visits in 3 years.
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
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hong Qi, MD, doctorqihong@163.com
About this study
To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could successfully be predictse and fundamentally facilitate diabetes management.
Read the detailed description
To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.This study will first conduct a prospective single-center cohort, which will enroll 250 type 2 diabetes mellitus patients with non-proliferative diabetic retinopathy (NPDR). The follow-up time points will be 3 months, 6 months, 1 year, 2 years, and 3 years after enrollment or reaching the endpoint (any condition that needs retinal photocoagulation, anti-vascular endothelial growth factor injections, and pars plana vitrectomy). The study will collect both patient clinical characteristics and multi-model eye imaging. With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could successfully be predictse and fundamentally facilitate diabetes management.
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, artificial intelligence model, multimodal eye imaging
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
DRSS Score and Classification
The progression of DR is based on the increase of DRSS score and classification.
Ophthalmologists at the Department of Ophthalmology, Peking University Third Hospital, will independently read UWF CFP in a semi-quantitative manner to assess the severity of DR based on the DRSS.
Progression of DR in T2DM patients with varying degrees of NPDR is calculated based on DRSS. An increase of at least one level in grading is considered progression. For instance, progression from grade 43A to 47A or higher is considered progression, while progression from 43A to 43B is not.
Measured: At Enrollment
Secondary outcomes (2)
Renal Function Test
Progression to DN is considered when the UACR increases from < 30 mg/g to ≥ 30 mg/g.
Measured: At Enrollment
Peripheral Neuropathy Assessment
Progression to DPN is considered when the MNSI score questionnaire section ≥ 4 points, while the examination section ≥ 2 points.
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (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.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- 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
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727955
- Sponsor's protocol ID
- M2023514
- Status last verified
- Nov 2024
- First submitted
- 6 Dec 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study on Predicting the Progression of Diabetic Microangiopathy Using Multimodal Eye Imaging
- ClinicalTrials.gov ID
- NCT06727955
- Acronym / sponsor ID
- M2023514
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, artificial intelligence model, multimodal eye imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 11 Dec 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.
To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could successfully be predictse and fundamentally facilitate diabetes management.
Detailed description
To develop an artificial intelligence (AI) model to predict DR progression based on a prospective cohort database.This study will first conduct a prospective single-center cohort, which will enroll 250 type 2 diabetes mellitus patients with non-proliferative diabetic retinopathy (NPDR). The follow-up time points will be 3 months, 6 months, 1 year, 2 years, and 3 years after enrollment or reaching the endpoint (any condition that needs retinal photocoagulation, anti-vascular endothelial growth factor injections, and pars plana vitrectomy). The study will collect both patient clinical characteristics and multi-model eye imaging. With use of an innovative AI model and a validated machine learning algorithm, based on multimodal vascular and neuro imaging of the eye, the progression of diabetic microangiopathy especially the DR could successfully be predictse and fundamentally facilitate diabetes management.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. age between 40 and 80 years, regardless of gender, 2. meet the diagnostic criteria of T2DM based on the Standards of Medical Care in Diabetes (2021)11, and complete evaluation at the Endocrinology Department of Peking University Third Hospital, 3. meet the Diabetic Retinopathy Severity Scale (DRSS) score level of mild to moderate-severe NPDR (i.e. 35 ≤ DRSS level ≤ 60, as shown in eTables 1 \& 2 in the Supplement) based on the montages ultra-widefield (UWF) fundus photographs,12 without clinically significant macular edema (CSME, defined as one or more of the followings: retinal thickening at or within 500 μm of the center of the macula; hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; or a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula),13 4. willing to sign the informed consent form.
Key inclusion criteria (1 listed)
- (1) age between 40 and 80 years, regardless of gender, (2) meet the diagnostic criteria of T2DM based on the Standards of Medical Care in Diabetes (2021)11, and complete evaluation at the Endocrinology Department of Peking University Third Hospital, (3) meet the Diabetic Retinopathy Severity Scale (DRSS) score level of mild to moderate-severe NPDR (i.e. 35 ≤ DRSS level ≤ 60, as shown in eTables 1 \& 2 in the Supplement) based on the montages ultra-widefield (UWF) fundus photographs,12 without clinically significant macular edema (CSME, defined as one or more of the followings: retinal thickening at or within 500 μm of the center of the macula; hard exudates at or within 500 μm of the center of the macula, if associated with adjacent retinal thickening; or a zone or zones of retinal thickening one disc area in size, at least part of which is within one disc diameter of the center of the macula),13 (4) willing to sign the informed consent form.
Key exclusion criteria (1 listed)
- (1) conjunctivitis, keratitis, blepharitis, episcleritis, scleritis, uveitis, severe dry eye disease, using anti-glaucoma eyedrops, or any condition causing conjunctival congestion or ciliary congestion, (2) pterygium, wearing contact lens in the past week, ocular surface burn, conjunctival tumors, or any condition causing significant conjunctival vascular deformities, (3) previously undergone intraocular surgeries involving manipulation of the conjunctiva, or corneal refractive surgery, (4) history of hematological disorder, dysthyroidism, rheumatic disorder, malignant tumor, (5) refractive media opacity resulting in poor visualization of fundus photographs, (6) difficulty in maintaining fixation or comprehension, making it challenging to cooperate with the examination, (7) difficulty in completing follow-up visits in 3 years.
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
DRSS Score and Classification
Time frame: At Enrollment
The progression of DR is based on the increase of DRSS score and classification. Ophthalmologists at the Department of Ophthalmology, Peking University Third Hospital, will independently read UWF CFP in a semi-quantitative manner to assess the severity of DR based on the DRSS. Progression of DR in T2DM patients with varying degrees of NPDR is calculated based on DRSS. An increase of at least one level in grading is considered progression. For instance, progression from grade 43A to 47A or higher is considered progression, while progression from 43A to 43B is not.
2 secondary outcomes
Renal Function Test
Time frame: At Enrollment
Peripheral Neuropathy Assessment
Time frame: At Enrollment
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 11 Dec 2024.
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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.
Hong Qi, Dr. principal investigator
Peking University Third 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, run by Peking University Third Hospital 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Dec 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 Hong Qi, Dr. (+8613901066889 ext. 010, doctorqihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DRSS Score and Classification (time frame: At Enrollment). 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 11 Dec 2024.