Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Intravitreal Brolucizumab: 6mg/0.05 ml Intravitreal Brolucizumab at baseline and follow up when indicated.
Duration is 1 year
Control Intervention1: Oral Multivitamin: Oral multivitami
Sponsors
L V Prasad Eye Institute
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults = 18 years 2. ETDRS BCVA of 20/40 to 20/320 (73 to 24 letters) in the study eye 3. OCT documentation of persistent subretinal fluid for 3 consecutive months prior to enrolment in the study 4. OCT showing persistent subretinal fluid with pigment epithelial detachment on OCT and/or intraretinal fluid 5. Men and women of childbearing potential must be willing to utilize adequate contraception and not become pregnant during the full course of the study 6. Willing, committed and able to return for ALL clinic visits and complete all study-related procedures. 7. Willingness to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.OCT-angiography (OCTA) showing net in outer retinal or choriorcapillaris slab suggestive of CNVM 2.FFA and ICGA features suggestive of CNVM 3.Any other macular abnormality not attributable to CSCR 4.Previous treatment with anti-VEGF agents 5.Concurrent disease in study eye that would require medical and/or surgical intervention not defined in the study period 6.Evidence at examination of infectious blepharitis, keratitis, scleritis or conjunctivitis in either eye or current treatment for serious systemic infection 7.History of cerebral vascular accident or myocardial infarction within 6 months prior to day 1 8.Renal failure requiring dialysis or renal transplant 9.Participation in an investigational study within 30 days prior to initial screening visit that involved treatment with any drug (excluding vitamins and minerals) or device 10.History of other disease, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, might affect the interpretation of results of the study, or renders the subject at high risk from treatment complications 11.Pregnancy or lactation 12.History of allergy to fluorescein used in fluorescein angiography 13.History of allergy to povidone iodine 14.Inability to obtain OCT or FFA of sufficient quality to be analysed by the site
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1)OCT fluid reduction of 20% compared to baseline or complete resolution at 1 month follow upTimepoint: 1 & 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Proportion of patients with same visual acuity and/or =5 letter loss in visual acuity on ETDRS chart at 3 months 2) Proportion of patients developing signs of anterior segment inflammation and/or vasculitis following intravitreal Brolucizumab Timepoint: 1 & 3 months | — |
Countries
India
Contacts
Public ContactDrSrishti Ramamurthy
L V Prasad Eye Institute
Outcome results
None listed