Diabetic RetinopathyNCT03264976
Role of the Serum Exosomal miRNA in Diabetic Retinopathy (DR)
An observational study of Diabetic Retinopathy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Trial summary
Diabetic retinopathy (DR) is one of the most common causes of blindness worldwide. It is a progressive disease and its detection in early phases is very crucial for visional outcomes. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- hematological examination, ophthalmic examination
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2018to 1 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients will be chosen according to the inclusion and exclusion standard and written informed consent will be obtained from all participants. Exit criteria： During the research, for his / her own consideration or at the request of the investigator the patient may withdraw from the trial at any time. For each subject who withdrew from the trial, the investigator must detail the subject's exit date, the reason, and other information in case report form（CRF）.
Who may be able to join
- Type II diabetics,
- Age > 18 years old,
- Have not accepted anti-VEGF therapy,
- Without turbid ocular media or corestenoma that interfere with ophthalmic fundus examination (patients with PDR are excluded).
Who cannot join
- -Patients with any following eye disease in studied eye:
- active infections (i.e., blepharitis, keratitis, scleritis, conjunctivitis, etc.),
- fundus oculi diseases other than DR (i.e., retinal vein occlusion, choroidal neovascularization, retinal detachment, macular hole, vitreous traction in macular region, epiretinal membrane, etc.) ,
- uncontrollable glaucoma (intraocular pressure is no less than 25mmHg after anti-glaucoma agents) or after filtering surgery for glaucoma;
- -Patients who have accepted any following treatment in studied eyes:
- intraocular injection of corticosteroids (i.e., Triamcinolone) within 3 months, or peribulbar injection of corticosteroids within 1 months,
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- vitrectomy surgery,
- anti-VEGF therapy for eyes or other parts of the body (i.e., ranibizumab, bevacizumab, conbercept, aflibercept, pegaptanib sodium, etc),
- any intraocular surgery within 3 months (i.e., cataract surgery, YAG laser capsulectomy, etc),
- ocular surgery related with macular region;
- -Patients with any following systemic diseases:
- failed blood sugar control within 3 months (Changing treatment from oral antidiabetic therapy into insulin treatment, or start using insulin pump, or doubling the number of injections),
- damaged renal function (Crea is found to be 2 times higher than the upper limit in central laboratory) or abnormal liver function (ALT, AST are found to be 2 times higher than the upper limit in center of the laboratory),
- failed blood pressure control within 3 months (systolic blood pressure is no less than 140 mmHg or diastolic blood pressure is no less than 90 mmHg after hypotensor treatment),
- systemic infection that requires oral, intramuscular or intravenous administration,
- stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure within 6months,
- coagulation dysfunction (thrombin time ≥ normal upper limit of 3 seconds, activation of partial thromboplastin time ≥ normal upper limit of 10 seconds),
- using drugs that may be toxic to the lens, retina or optic nerve during this research (i.e., deferoxamine, chloroquine, hydrogenated chloroquine (chloroquinol), tamoxifen, phenothiazine, or ethambutol, etc.),
- diagnosed systemic immune diseases (i.e., mandatory spondylitis, systemic lupus erythematosus, etc.) or any uncontrollable clinical diseases (such as AIDS, malignancy, active hepatitis, severe mental, neurological, cardiovascular, respiratory and other systems diseases, etc.);
- -Others:
- pregnant and lactating women,
- those who participated in any drug clinical trials (not including vitamins and minerals) within 3 months,
- those researchers believe that need to be excluded.
About this study
Official title: Prognostic Role of Serum Exosomal miRNA and Its Function in Pathogenesis of Diabetic Retinopathy (DR)
Diabetic retinopathy (DR) is one of the most common causes of blindness worldwide. It is a progressive disease and its detection in early phases is very crucial for visional outcomes. miRNA of exosomes has been recently considered as a potential circulating marker of oculopathy, including age-related macular degeneration and uveal melanoma. Therefore, the primary objective of this study is to evaluate whether the serum exosomal miRNA could be prospective prognosis biomarker to investigate the initiation and development of DR. This case-control study is planned to include diabetic patients, and patients without DR, which serve as controls. Other participants will be divided into four groups by different DR stages according to the guideline from AAO. Information and samples of all trial participants will be collected at the inception of the study, including basic information, medical history, serum samples, and several ophthalmologic examinations. Then these information and examinations will be collected at regular intervals: every 12 months until 5 years. Different statistical methods will be used to identify significant associations between DR progression and different exosomal miRNA. We hypothesis that there could exist alert level of exosomal miRNAs which indicate the onset and development of DR in diabetic patients. Moreover, the selected exosomal miRNAs, being considered together with other information including medical history, blood indicators and ophthalmologic examinations, to be chosen-optimized as a prognostic model for DR, which may help predicting high risk groups of DR and those with poor prognosis. Based on clinical trial data, we will further discuss about possible roles of identified miRNA of exosomes in the pathogenesis of DR.
- Conditions
- Diabetic Retinopathy
- Being tested
- hematological examination, ophthalmic examination
- Keywords
- diabetic retinopathy, miRNA, serum exosomes, prognostic biomarker
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hematological examination, ophthalmic examinationDiagnostic test
Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP)；Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients without DR. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years. Receives: Diagnostic Test: hematological examination, ophthalmic examination | |
| Group 2 | Patients with mild non-proliferative DR (NPDR). Diagnosed according to Diabetic retinopathy PPP - Updated 2016.
Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years. Receives: Diagnostic Test: hematological examination, ophthalmic examination | |
| Group 3 | Patients with moderate NPDR. Diagnosed according to Diabetic retinopathy PPP - Updated 2016.
Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination.These information and examinations will be collected at regular intervals: every 12 months until 5 years. Receives: Diagnostic Test: hematological examination, ophthalmic examination | |
| Group 4 | Patients with moderate NPDR. Diagnosed according to Diabetic retinopathy PPP - Updated 2016.
Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years. Receives: Diagnostic Test: hematological examination, ophthalmic examination | |
| Group 5 | Proliferative DR (PDR). Diagnosed according to Diabetic retinopathy PPP - Updated 2016.
Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination.These information and examinations will be collected at regular intervals: every 12 months until 5 years. Receives: Diagnostic Test: hematological examination, ophthalmic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
exosomal miRNAs in serum samples
In discovery set, miRNA sequencing of serum exosomes will be performed for each sample. Data will be analyzed using statistical methods. Potential miRNAs that show group-differentiation will be selected in combination with information and test results.Based on these selected miRNAs, the same assays will be repeated on all validation set samples to screen out significant miRNA.
Measured: samples will be collected every 12 months later until 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2023 (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 Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun Liu, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264976
- Sponsor's protocol ID
- 2017-KE-194
- Status last verified
- Aug 2017
- First submitted
- 25 Aug 2017
- Last updated
- 29 Aug 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Role of Serum Exosomal miRNA and Its Function in Pathogenesis of Diabetic Retinopathy (DR)
- ClinicalTrials.gov ID
- NCT03264976
- Acronym / sponsor ID
- 2017-KE-194
- Conditions
- Diabetic Retinopathy
- Keywords
- diabetic retinopathy, miRNA, serum exosomes, prognostic biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 29 Aug 2017 (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.
Diabetic retinopathy (DR) is one of the most common causes of blindness worldwide. It is a progressive disease and its detection in early phases is very crucial for visional outcomes. miRNA of exosomes has been recently considered as a potential circulating marker of oculopathy, including age-related macular degeneration and uveal melanoma. Therefore, the primary objective of this study is to evaluate whether the serum exosomal miRNA could be prospective prognosis biomarker to investigate the initiation and development of DR. This case-control study is planned to include diabetic patients, and patients without DR, which serve as controls. Other participants will be divided into four groups by different DR stages according to the guideline from AAO. Information and samples of all trial participants will be collected at the inception of the study, including basic information, medical history, serum samples, and several ophthalmologic examinations. Then these information and examinations will be collected at regular intervals: every 12 months until 5 years. Different statistical methods will be used to identify significant associations between DR progression and different exosomal miRNA. We hypothesis that there could exist alert level of exosomal miRNAs which indicate the onset and development of DR in diabetic patients. Moreover, the selected exosomal miRNAs, being considered together with other information including medical history, blood indicators and ophthalmologic examinations, to be chosen-optimized as a prognostic model for DR, which may help predicting high risk groups of DR and those with poor prognosis. Based on clinical trial data, we will further discuss about possible roles of identified miRNA of exosomes in the pathogenesis of DR.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: hematological examination, ophthalmic examinationPatients without DR. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years. |
| Group 2 | – | Diagnostic Test: hematological examination, ophthalmic examinationPatients with mild non-proliferative DR (NPDR). Diagnosed according to Diabetic retinopathy PPP - Updated 2016. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years. |
| Group 3 | – | Diagnostic Test: hematological examination, ophthalmic examinationPatients with moderate NPDR. Diagnosed according to Diabetic retinopathy PPP - Updated 2016. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination.These information and examinations will be collected at regular intervals: every 12 months until 5 years. |
| Group 4 | – | Diagnostic Test: hematological examination, ophthalmic examinationPatients with moderate NPDR. Diagnosed according to Diabetic retinopathy PPP - Updated 2016. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination. These information and examinations will be collected at regular intervals: every 12 months until 5 years. |
| Group 5 | – | Diagnostic Test: hematological examination, ophthalmic examinationProliferative DR (PDR). Diagnosed according to Diabetic retinopathy PPP - Updated 2016. Information and samples of all trial participants at enrollment will be collected at the inception of the study, including: basic information, basic medical records, hematological examination, ophthalmic examination.These information and examinations will be collected at regular intervals: every 12 months until 5 years. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be chosen according to the inclusion and exclusion standard and written informed consent will be obtained from all participants. Exit criteria： During the research, for his / her own consideration or at the request of the investigator the patient may withdraw from the trial at any time. For each subject who withdrew from the trial, the investigator must detail the subject's exit date, the reason, and other information in case report form（CRF）.
Key inclusion criteria (4 listed)
- Type II diabetics,
- Age > 18 years old,
- Have not accepted anti-VEGF therapy,
- Without turbid ocular media or corestenoma that interfere with ophthalmic fundus examination (patients with PDR are excluded).
Key exclusion criteria (23 listed)
- active infections (i.e., blepharitis, keratitis, scleritis, conjunctivitis, etc.),
- fundus oculi diseases other than DR (i.e., retinal vein occlusion, choroidal neovascularization, retinal detachment, macular hole, vitreous traction in macular region, epiretinal membrane, etc.) ,
- uncontrollable glaucoma (intraocular pressure is no less than 25mmHg after anti-glaucoma agents) or after filtering surgery for glaucoma;
- intraocular injection of corticosteroids (i.e., Triamcinolone) within 3 months, or peribulbar injection of corticosteroids within 1 months,
- vitrectomy surgery,
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 |
|---|---|---|
| hematological examination, ophthalmic examinationHematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP)；Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging. | Diagnostic test | Group 1, Group 2, Group 3, Group 4, Group 5 |
Primary outcome
exosomal miRNAs in serum samples
Time frame: samples will be collected every 12 months later until 5 years
In discovery set, miRNA sequencing of serum exosomes will be performed for each sample. Data will be analyzed using statistical methods. Potential miRNAs that show group-differentiation will be selected in combination with information and test results.Based on these selected miRNAs, the same assays will be repeated on all validation set samples to screen out significant miRNA.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2017.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
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 23 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: status not confirmed, as of the sponsor's last update on 29 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
exosomal miRNAs in serum samples (time frame: samples will be collected every 12 months later until 5 years). 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 29 Aug 2017.