Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: Asses the efficacy and safety of brolucizumab and aflibercept in patients with visual impairment due to DME.: Functional and anatomical outcomes measured were mean change in BCVA, CMT,
Sponsors
Dr Vipin Rana
Eligibility
Inclusion criteria
Inclusion criteria: 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 3. Patient or legally acceptable representative willing to voluntarily provide signed informed consent for participation in the study.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-inferiority of brolucizumab to aflibercept with respect to change in visual acuity from baseline upto week24Timepoint: 1 year 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the number of anti-VEGF injections, non-injection visits,and total number of visits during the study, to evaluate the effectiveness of brolucizumab on fluid(IRF,SRF) from baseline to 4th week 8th week,12th week & 24 th week to evaluate the effectiveness of brolucizumab on central retinal thickness from baseline to week 24Timepoint: 1year 6 months | — |
Countries
India
Contacts
Public ContactSatyaki Mondal
Command Hospital, Eastern Command
Outcome results
None listed