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Clinical Trials/CTRI/2023/06/053778
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
V Prasad Eye Institute

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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