CTRI/2023/06/053778
Recruiting
未知
A Randomized, Placebo-controlled Study of the Efficacy, Safety & Tolerability of Intravitreal Brolucizumab in patients with Chronic Central Serous Chorioretinopathy with persistent fluid in the absence of choroidal neovascular membrane - BRICS
V Prasad Eye Institute0 sites0 target enrollmentTBD
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
- Sponsor
- V Prasad Eye Institute
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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