- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Anticipato)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
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).
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
exosomal miRNAs in serum samples
Lasso di tempo: 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.
|
samples will be collected every 12 months later until 5 years
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2017-KE-194
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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