- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03264976
Role of the Serum Exosomal miRNA in Diabetic Retinopathy (DR)
Prognostic Role of Serum Exosomal miRNA and Its Function in Pathogenesis of Diabetic Retinopathy (DR)
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Odotettu)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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).
Kuvaus
Inclusion Criteria:
- 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).
Exclusion Criteria:
-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,
- 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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
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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.
|
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.
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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. |
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.
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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. |
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.
|
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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. |
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.
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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. |
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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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exosomal miRNAs in serum samples
Aikaikkuna: 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.
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samples will be collected every 12 months later until 5 years
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Yhteistyökumppanit ja tutkijat
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Odotettu)
Ensisijainen valmistuminen (Odotettu)
Opintojen valmistuminen (Odotettu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
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Muita asiaankuuluvia MeSH-ehtoja
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Kliiniset tutkimukset Diabeettinen retinopatia
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Washington University School of MedicineValmisCentral Serous Retinopathy (CSR)Yhdysvallat