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CTRI Number  CTRI/2023/06/053778 [Registered on: 12/06/2023] Trial Registered Prospectively
Last Modified On: 13/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Intravitreal Brolucizumab in management of Chronic Central Serous Chorioretinopathy  
Scientific Title of Study   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  
Trial Acronym  BRICS 
Secondary IDs if Any  
Secondary ID  Identifier 
LVPEI_CSCR_11  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrSrishti Ramamurthy 
Designation  Fellow of Retina & Vitreous 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute,Kallam Anji Reddy Campus, GPR building,1st floor,Room No:123, Clinical Research Department,Road No:02,Banjara hills,Hyderabad 500034, Telangana,India

Hyderabad
TELANGANA
500034
India 
Phone    
Fax  04023548271  
Email  srishti.ramamurthy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSrishti Ramamurthy 
Designation  Fellow of Retina & Vitreous 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute,Kallam Anji Reddy Campus, GPR building,1st floor,Room No:123, Clinical Research Department,Road No:02,Banjara hills,Hyderabad 500034, Telangana,India

Hyderabad
TELANGANA
500034
India 
Phone    
Fax  04023548271  
Email  srishti.ramamurthy@gmail.com  
 
Details of Contact Person
Public Query  
Name  DrSrishti Ramamurthy 
Designation  Fellow of Retina & Vitreous 
Affiliation  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute,Kallam Anji Reddy Campus, GPR building,1st floor,Room No:123, Clinical Research Department,Road No:02,Banjara hills,Hyderabad 500034, Telangana,India

Hyderabad
TELANGANA
500034
India 
Phone    
Fax  04023548271  
Email  srishti.ramamurthy@gmail.com  
 
Source of Monetary or Material Support  
L V Prasad Eye Institute, Kallam Anji Reddy Campus, GPR building,1st floor,Room No:123, Clinical Research Department,Road No:02,Banjara hills,Hyderabad 500034, Telangana,India  
 
Primary Sponsor  
Name  L V Prasad Eye Institute 
Address  L V Prasad Eye Institute, Kallam Anji Reddy Campus, GPR building,1st floor, Room No:123, Clinical Research Department, Road No:02,Banjara hills, Hyderabad 500034, Telangana,India  
Type of Sponsor  Other [Non profitable organization] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrSrishti Ramamurthy  L V Prasad Eye Institute  Kallam Anji Reddy Campus, GPR building,1st floor,Room No:123, Clinical Research Department,Road No:02,Banjara hills,Hyderabad 500034, Telangana,India
Hyderabad
TELANGANA 		 9566377755
04023548271
srishti.ramamurthy@lvpei.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee, L V Prasad Eye Institute  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H32||Chorioretinal disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intravitreal Brolucizumab  6mg/0.05 ml Intravitreal Brolucizumab at baseline and follow up when indicated. Duration is 1 year 
Comparator Agent  Oral Multivitamin  Oral multivitamins (placebo group) on a daily basis for the duration of the study  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1) OCT fluid reduction of 20% compared to baseline or complete resolution at 1 month follow up   1 & 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
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
 		 1 & 3 months 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/06/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="1"
Days="1" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 none 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

This is a prospective randomized, placebo-controlled trial where patients with chronic CSCR (presence of subretinal/intraretinal fluid on OCT for ≥ 3months) in the absence of Choroidal Neovascular Membrane will be recruited. Patients will be randomized to receive intravitreal Brolucizumab or placebo (oral multivitamins). OCT resolution of fluid and best corrected visual acuity will be studied at 1 and 3 months follow up in all patients.

 

 
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