Diabetic macular edema
Conditions
Interventions
experiment group:calcium dobesilate (doxium)
control group:placebo
Sponsors
The First Affiliated Hospital of Jinan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Aged 18 years, no gender limit; 2) Diagnosed as type I or type II diabetes; 3) Glycated hemoglobin (HbA1c) value = 24 letters and = 24 letters (equivalent to 20/320 of Snellen's vision); 7) Sign the informed consent form, and be willing to take the medicine and follow-up at the time specified in the trial.
Exclusion criteria
Exclusion criteria: 1) Any eye has active eye infection (such as blepharitis, keratitis, scleritis, conjunctivitis, etc.); 2) The target eye has proliferative diabetic retinopathy (PDR), except for PDR that resolves after panretinal photocoagulation, inactive, and fibrosis; 3) The target eye has a history of vitreous hemorrhage within 3 months before screening; 4) The target eye has structural damage to the retina that affects the fovea (such as retinal pigment epithelial atrophy, retinal fibrosis, laser scars, intensive hard exudation), or the researcher believes that the target eye may hinder the improvement of vision after the resolution of macular edema Retinal damage; 5) Except for diabetes, the target eye has other ophthalmic conditions that cause macular edema or vision changes (such as retinal vein occlusion, choroidal neovascularization, retinal detachment, macular hole, macular retinal traction, epiretinal membrane, etc.); 6) The target eye has iris neovascularization; 7) The target eye has uncontrollable glaucoma (defined as intraocular pressure >= 25mmHg after anti-glaucoma treatment), or a history of glaucoma filtering surgery; 8) The researcher believes that the target eye cataract may affect the judgment of the examination or test results, or require surgical treatment in the next 6 months; 9) The target eye has no lens (if intraocular lens can be included); Eye treatment: 10) Either eye has received intraocular corticosteroid injections (such as triamcinolone acetonide) within 3 months before screening, or intraocular corticosteroid injections within 1 month before screening; 11) The target eye has a history of vitrectomy; 12) The target eye has received retinal photocoagulation (including macular grid photocoagulation) within 3 months before screening; 13) The target eye or systemic system has been treated with anti-VEGF drugs (such as aflibercept, pegatanib sodium, ranibizumab, bevacizumab, etc.) within 3 months before screening, or the non-target eye Received anti-VEGF drug treatment within 3 months before the screening period; 14) The target eye has undergone any intraocular surgery (such as cataract surgery, etc.) within 3 months before screening; 15) The target eye has undergone ophthalmic surgery involving the macular area (such as macular peeling, etc.); Systemic diseases: 16) In the 3 months before the screening, blood sugar control is not satisfactory (defined as changing from oral hypoglycemic therapy to insulin therapy, starting insulin pump therapy or doubling the number of daily insulin injections); 17) Renal failure requiring dialysis or kidney transplantation or renal insufficiency with a creatinine level > 2.0 mg/dl. 18) Unsatisfactory blood pressure control (defined as systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 95 mmHg after treatment with antihypertensive drugs); 19) Existing systemic infections requiring oral, intramuscular or intravenous administration; 20) Stroke, transient ischemic attack, myocardial infarction or acute congestive heart failure occurred within 6 months before screening; 21) Abnormal blood coagulation function (prothrombin time >= 3 seconds of normal value, activated partial thromboplastin time >= 10 seconds of normal value); 22) Drugs that are toxic to the lens, retina or optic nerve (such as deferoxamine, chloroquine, hydroxychloroquine (chloroquinine), tamoxifen, phenothiazines, ethambutol, etc.) may be used during use or during research; 23) There is
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anti-VEGF frequency; | — |
Secondary
| Measure | Time frame |
|---|---|
| fluorescein fundus angiography;optical coherence tomography;best corrected visual acuity;CF; | — |
Countries
China
Contacts
Public ContactMeng Jing
The First Affiliated Hospital of Jinan University
Outcome results
None listed