Study to assess the efficacy and safety of brolucizumab and aflibercept in patients with visual impairment due to dme- a randomised clinical trial - Nil

Dr Vipin Rana0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年10月16日

试验速览

暂无简介。

•1. Male and female patients >18 years old with visual impairment due to DME.
•2. Patients with type 1 or type 2 diabetes mellitus and Hba1c of <10% at screening.
•3. Patient or legally acceptable representative willing to voluntarily provide signed informed consent for participation in the study.

•1. Patient with existing or suspected ocular or periocular infection in the study eye.
•2. Patient with uncontrolled glaucoma defined as intraocular pressure >25 mmhg despite treatment with antiglaucoma medication, or according to investigators judgement.
•3. Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
•4. Active proliferative diabetic retinopathy in the study eye as per investigator.
•5. Previous treatment with any anti-vegf drugs or investigational drugs in the study eye.
•6.Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 month period prior to baseline.
•7. Intraocular surgery including YAG laser in the study eye during the 3 month period prior to baseline.
•8. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.

发起方

Dr Vipin Rana