Correlation between imaging and molecular biomarkers in diabetic macular edema

PGIMER Chandigarh0 个研究点目标入组 18 人开始时间: 待定最近更新: 2023年9月18日

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•1.Patients age = 18 years.
•2.Patients with type 1 or type 2 diabetes mellitus with Non proliferative diabetic retinopathy + treatment naive central diabetic macular edema or treated Proliferative diabetic retinopathy + central diabetic macular edema (defined as retinal thickening with a measurement of 300µm or more involving the 1 mm CRT by SS-OCT).
•3.No prior history of Intravitreal Anti VEGF in either eye and laser photocoagulation done in last 3 months.
•4.The cause of decreased vision in the study eye attributed primarily to DME.
•5.BCVA in Snellen visual acuity of 20/40 to 20/320 in the study eye.
•6.In female in child bearing age, a negative serum pregnancy test before enrollment, and should not be nursing or planning a pregnancy.

•1.Media haze that would interfere with good imaging.
•2.Known hypersensitivity to fluorescein
•3.History of vitreoretinal surgery in study eye and/or including scleral buckling.
•4.Pan retinal or macular laser photocoagulation within 3 months of randomization
•5.Active ocular inflammation or uveitis
•6.Cataract or other intraocular surgery within 3 months of enrollment into the study
•8.Visually significant vitreomacular traction or epiretinal membrane evident biomicroscopically or on OCT that is thought to affect central vision.
•9.Active iris neovascularisation
•10.Preretinal fibrosis involving the macula.
•11.Active or suspected ocular or peri-ocular infection like infectious blepharitis, keratitis, scleritis, or conjunctivitis
•12.Uncontrolled diabetes mellitus as defined by HbA1c =10% at screening.
•13.Uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm of Hg.
•14.History of cerebrovascular accident or myocardial infarction within 6 months.
•15.Renal failure requiring dialysis or renal transplant.
•16.Co morbidities like vein occlusions, retinal detachment etc. that may contribute to visual loss.

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