Intravitreal Brolucizumab in management of Chronic Central Serous Chorioretinopathy
- Conditions
- Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
- Registration Number
- CTRI/2023/06/053778
- Lead Sponsor
- V Prasad Eye Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)OCT fluid reduction of 20% compared to baseline or complete resolution at 1 month follow upTimepoint: 1 & 3 months
- Secondary Outcome Measures
Name Time Method 1)Proportion of patients with same visual acuity and/or =5 letter loss in visual acuity on ETDRS chart at 3 months <br/ ><br>2)Proportion of patients developing signs of anterior segment inflammation and/or vasculitis following intravitreal Brolucizumab <br/ ><br>Timepoint: 1 & 3 months