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CTRI Number  CTRI/2023/03/050939 [Registered on: 21/03/2023] Trial Registered Prospectively
Last Modified On: 12/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial/study for Patients With Polypoidal Choroidal Vasculopathy 
Scientific Title of Study   A Phase IIIb/IV, Multicenter, Open-Label, Single-Arm Study To Investigate The Efficacy And Safety Of Faricimab (RO6867461) In Patients With Polypoidal Choroidal Vasculopathy 
Trial Acronym  SALWEEN 
Secondary IDs if Any  
Secondary ID  Identifier 
MR43808_Version 1 Addendum 1 dated 09Jan2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Viraj Suvarna 
Designation  Medical Chapter Lead 
Affiliation  Roche Products (India) Pvt. Ltd. 
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall

Mumbai
MAHARASHTRA
400086
India 
Phone  9820006317  
Fax    
Email  viraj.suvarna@roche.com  
 
Details of Contact Person
Public Query  
Name  Ms Priyanka Bhattacharya 
Designation  Lead-Clinical Operations 
Affiliation  Roche Products India Private Limited 
Address  Roche Products (India) Pvt. Ltd. 146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall

Mumbai
MAHARASHTRA
400086
India 
Phone  8879099480  
Fax    
Email  priyanka.bhattacharya@roche.com  
 
Source of Monetary or Material Support  
F HoffmannLa Roche Ltd CH-4070 Basel, Switzerland  
 
Primary Sponsor  
Name  F HoffmannLa Roche Ltd 
Address  Grenzacherstrasse 124, CH-4070 Basel, Switzerland  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Roche Products India Pvt Ltd  146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai 
 
Countries of Recruitment     China
Hong Kong
India
Japan
Malaysia
Republic of Korea
Singapore
Taiwan
Thailand  
Sites of Study
Modification(s)  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anand Rajendran  Aravind Eye Hospital  Postgraduate Institute of Ophthalmology, 10, Poonamallee High Road, Noombal, Chennai - 600077, Tamil Nadu, India
Chennai
TAMIL NADU 		 9894206777

anandrjn@gmail.com 
Dr Raja Narayanan  L V Prasad Eye Institute  Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Hyderabad-500034
Hyderabad
TELANGANA 		 9177111975

narayanan@lvpei.org 
Dr Muna Bhende  Sankara Nethralaya  Deputy director, Bhagwan Mahavir Vitreo retina services,7th floor, MAHYPO BLOCK, 18/41,College Road-600006
Chennai
TAMIL NADU 		 9444177233

drmuna@snmail.org 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
Institutional Review Board - Ethics Committee  Approved 
L V Prasad Eye Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
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  Faricimab (RO6867461)  faricimab 6 mg IVT injection administered at up to 104 weeks  
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Participants who are able to comply with the study protocol, in the investigator’s judgment.
For female participants of childbearing potential: agreement to remain abstinent or use contraception.
Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis.
Confirmed diagnosis, by the investigator, of symptomatic macular PCV.
BCVA scores of 7824 ETDRS letters, inclusive (20/32 to 20/320 approximate
Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters (see the BCVA manual for additional details) on study Day 1 
 
ExclusionCriteria 
Details  Treatment with investigational therapy (device, drug, or traditional medicine with the exception of vitamins and minerals) within 3 months prior to initiation of study treatment on study Day 1.
Any major illness or major surgical procedure within 1 month before screening.
Active cancer within the 12 months prior to study Day 1 except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer.
Systemic treatment for suspected or active systemic infection on study Day 1.
Uncontrolled blood pressure, while the participant is at rest on study Day 1.
History of stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to study Day 1.
Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 28 days after the final dose of faricimab.
History of idiopathic or autoimmune-associated uveitis in either eye.
Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1.
Any history or presence of macular pathology unrelated to PCV affecting vision or contributing to the presence of macular hemorrhage, IRF, or SRF.
Retinal pigment epithelial tear involving the macula on study Day 1.
Current vitreous hemorrhage on study Day 1.
Uncontrolled glaucoma.
Prior periocular pharmacological or IVT treatment (including anti-VEGF medication) for other retinal diseases.
Participants who have a non-functioning fellow (non study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non study eye (i.e., monocular), at
both the screening and study Day 1 visits will be excluded from study entry. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
The primary endpoint is the change from baseline in BCVA (as measured on the ETDRS
chart at a starting distance of 4 meters) based on an average at Weeks 40, 44, and 48. 		 Population: adult participants with PCV as defined by the inclusion or exclusion criteria mITT population).
Variable: change from baseline in BCVA score averaged over Weeks 40, 44, and 48 as measured using the ETDRS VA chart at a starting distance of 4 meters.
Population-level summary: Adjusted mean and associated 95% CI in the faricimab arm.

 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of IVT injections of faricimab on additional BCVA outcomes  Change from baseline in BCVA based on an average at Weeks 100, 104, and 108
Change from baseline in BCVA over time
Proportion of participants avoiding loss or gaining more than equal to 15, more than equal to 10, or more than equal to 5 letters in BCVA from baseline over time 
To evaluate the efficacy of IVT injections of faricimab on anatomic outcome measures using ICGA  Proportion of participants with complete polypoidal
lesion regressions at Weeks 16, 48, and 108 
To evaluate the efficacy of IVT injections of faricimab on anatomic outcomes measures using OCT  Change from baseline in CST based on an average at
Weeks 40, 44, and 48
Change from baseline in CST based on an average at
Weeks 100, 104, and 108
Change from baseline in CST over time 
To evaluate the durability of IVT injections of faricimab  Proportion of participants on a Q8W, Q12W, and Q16W treatment interval at Weeks 24, 44, and 108,
and Q20W at Week 108.
Number of faricimab injections received from Week 48 through Week 108 
To evaluate the ocular and non-ocular safety and tolerability of IVT injections of faricimab  Incidence and severity of ocular adverse events
Incidence and severity of non-ocular adverse events 
 
Target Sample Size   Total Sample Size="132"
Sample Size from India="10" 
Final Enrollment numbers achieved (Total)= "132"
Final Enrollment numbers achieved (India)="3" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   28/04/2023 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  02/03/2023 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
The purpose of this study is to assess the efficacy, durability, and safety of faricimab, a novel bispecific anti.vascular endothelial growth factor (VEGF)-A and anti-angiopoietin-2 (Ang-2) antibody, in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV), a subtype of neovascular age-related macular degeneration (nAMD), which was under-represented in the faricimab Phase III pivotal Studies GR40306 (TENAYA) and GR40844 (LUCERNE). Intravitreal (IVT) anti-VEGF agents are the standard of care for the management of PCV, with verteporfin photodynamic therapy (PDT) used as adjunct or rescue treatment. However, there remains an unmet need for therapies that alleviate treatment burden and provide sustained visual outcomes for patients with PCV.
 
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