Status:
UNKNOWN
Role of the Serum Exosomal miRNA in Diabetic Retinopathy (DR)
Lead Sponsor:
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
19+ years
Brief 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. miRNA of exosome...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03264976
Start Date
July 1 2018
End Date
July 1 2023
Last Update
August 29 2017
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