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CTRI Number  CTRI/2024/11/076857 [Registered on: 14/11/2024] Trial Registered Prospectively
Last Modified On: 25/02/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   To check the safety and effectiveness of Faricimab injection in India in patients with nAMD and DME.  
Scientific Title of Study   A Phase IV, Multicentrer, open-Label, Single-Arm Study in Patients with neovascular Age-Related Macular Degeneration or Diabetic Macular Edema to evaluate the safety and effectiveness of the Faricimab intravitreal Injection in India (VITREAL Study) 
Trial Acronym  VITREAL 
Secondary IDs if Any  
Secondary ID  Identifier 
ML45007_Version 2.0 dated 29 Apr 2024  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
Modification(s)  
Name  Dr Jyotii Poddaar 
Designation  Lead- Clinical Operations 
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, Lal Bahadur Shastri Marg, Ghatkopar

Mumbai
MAHARASHTRA
400086
India 
Phone  9136064373  
Fax    
Email  jyotii.poddaar@roche.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Manjula Ujagiri  
Designation  Manager-Clinical Operations 
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, Lal Bahadur Shastri Marg, Ghatkopar

Mumbai
MAHARASHTRA
400086
India 
Phone  022-50457300  
Fax    
Email  manjula.ujagiri@roche.com  
 
Source of Monetary or Material Support  
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 - 400086 - INDIA 
 
Primary Sponsor  
Name  Roche Products India Pvt Ltd 
Address  146-B, 166 A, Unit No. 7, 8, 9 8th Floor, R City Office, R City Mall Lal Bahadur Shastri Marg Ghatkopar, Mumbai 400086 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopal Pillai  Amrita Institute of Medical Sciences  Amrita Institute of Medical Sciences and Research centre, Department of Ophthalmology, G block- Ground Floor, P.O. AIMS Ponekkara, Kochi 682041, Kerala, India
Ernakulam
KERALA 		 9447391266

gopalspillai@gmail.com 
Dr Dinesh Talwar  Centre for Sight Eye Institute  Centre for Sight Eye Institute , Department, Ophthalmologist and Vitreo retina Specialist, Room No-2 and 3 Ground Floor, B5/24, Safdarjung Enclave, Opposite Deer Park, Humayunpur, New Delhi - 110029 India
New Delhi
DELHI 		 9810302298

dineshtalwar@yahoo.co.uk 
Dr Shorya Azad  Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS  Dr. Rajendra Prasad Centre for Ophthalmic Sciences, Department of Opthalamology, AIIMS, Ansari Nagar, New Delhi, 110023 - India
New Delhi
DELHI 		 9193120157

shoryaazad@gmail.com 
Dr Brijesh Takkar  L V Prasad Eye Institute  L V Prasad Eye Institute, Room no:123, First floor, GPR Building Kallam Anji Reddy Campus, L.V. Prasad Marg, Opp PVR mall, Banjara Hills, Hyderabad, Telangana, India, 500034 - India
Hyderabad
TELANGANA 		 9868092215

brijeshtakkar@lvpei.org 
Dr Soumyadeep Majumdar  Regional Institute of Ophthalmology  Regional Institute of Ophthalmology 88 College Street, Kolkata -700 073, West bengal, India
Kolkata
WEST BENGAL 		 9647683105

soumyanbmc@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Centre for Sight Institutional Ethics Committee  Approved 
Institute Ethics Committee for biomedical and Health Research - AIIMS  Approved 
Institutional Ethics Committee Amrita Institute of Medical Sciences  Approved 
Institutional Ethics Committee for Human Research  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: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  VABYSMO  - Clear to Opalescent, colorless to brownish-yellow solution Injection in a single dose glass vial containing 28.8mg Faricimab in 0.24 mL solution. -The study duration will be approximately 18 months which will include screening and enrollment phase and treatment phase. For each participant the duration of the study will be approximately 5 months (20 weeks). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Willing to provide voluntary written informed consent.
2. Willing and able to comply with clinic visits and study-related procedures.
3. Confirmed diagnosis of neovascular age-related macular degeneration (nAMD; any subtype) or diabetic macular edema in one or both eyes by the study site investigator (only one eye will be selected as the study eye, as determined by the retina specialist) with onset at any time prior to study start.
5. For patients with nAMD:
5a. Active subfoveal choroidal neovascularization secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by OCT in the study eye, as determined by the investigator.
5b. Treatment naive.
5c. BCVA of 78 to 24 letters, inclusive (20/32 to 20/320 approximate Snellen equivalent), using the ETDRS protocol and assessed at the initial testing distance of 4 meters on Day 1.
6. For patients with DME:
6a. Patients with clinically significant DME with central involvement (greater than or equal to 325 μm in the Central subfoveal thickness on OCT).
6b. Treatment naive.
6c. BCVA of 73 to 25 letters, inclusive (20/40 to 20/320 approximate Snellen equivalent), using the ETDRS protocol at the initial testing distance of 4 meters on Day 1.
7. HbA1c of less than or equal to 10% within 2 months prior to the Day 1 visit date.
8. Study eye is deemed to be indicated for Faricimab intravitreal treatment at the discretion of the retina specialist.
9. Historical optical coherence tomography data available for the study eye within 30 days prior to Day 1.
10. For female patients of childbearing potential: agree to remain abstinent or use contraception, and agree to refrain from donating eggs, as defined in the protocol.



 
 
ExclusionCriteria 
Details  1. Pregnancy or breastfeeding, or intention to become pregnant during the study or within 3 months after the final dose of Faricimab.
2. Requirement on Day 1 for continuous use of any medications and treatments considered prohibited therapy per the protocol.
3. Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals) within 3 months prior to Day 1.
4. Subject with vision only in one eye.
5. Laser photocoagulation in the study eye within 1 month before screening the subject.
6. Stroke or myocardial infarction within 6 months prior to Day 1.
7. History of other diseases, metabolic dysfunction, physical examination finding or clinical laboratory finding giving reasonable suspicion of a condition that contraindicates the use of Faricimab or renders the patient at high risk for treatment complications in the opinion of the investigator.
8. Uncontrolled hypertension.
9. Patients with cataracts and patients at risk of developing cataracts during the study period Systemic treatment for suspected or active systemic infection on Day 1
10. Legally blind in the study eye on Day 1 (Best-corrected visual acuity of 20/200 or less).
11. History of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction, including non-infectious uveitis or infectious uveitis, or sterile inflammatory reaction after previous IVT injections with any agent in either eye.
12. Suspected or active ocular or periocular infection in either eye on Day 1.
13. Subfoveal fibrosis or Subfoveal atrophy in the study eye.
14. History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular or subconjunctival bleeding or hemorrhages after IVT injection or intraocular procedures in either eye.
15. Uncontrolled glaucoma in the study eye.
16. Prior treatment with any intravitreal drug in the study eye in the past and/or non-study eye within the past 3 months before enrollment in the study.
17. Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation in the study eye at any time during the 3 months prior to Day 1.
18. Any other condition that in the opinion of investigator could hamper participation in the study.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment    
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
nAMD & DME: Incidence of treatment-emergent adverse events (TEAEs)   baseline to Week 16 
 
Secondary Outcome  
Outcome  TimePoints 
nAMD & DME: Mean change from baseline in BCVA in the study eye in patients with nAMD   At Week 16 
nAMD: Change from baseline in BCVA in the study eye in patients with nAMD over time.   At Baseline, Weeks 4, 8, 12 
nAMD & DME: Change from baseline in Central subfoveal thickness on OCT in the study eye.  At Week 16 
nAMD & DME: Change from baseline in Central subfoveal thickness on OCT in the study eye over time.   At Baseline, Weeks 4, 8,12 & 16 
DME: Change from baseline in BCVA in the study eye in patients with DME over time  At Baseline, Weeks 4, 8,12 & 16 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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   Phase 4 
Date of First Enrollment (India)   15/06/2025 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
This is a Phase IV, Open-Label, Single-Arm Study in Patients With NeoVascular Age-Related Macular Degeneration or Diabetic Macular Edema to Evaluate the Safety and Effectiveness of the Faricimab  intravitREAL injection in India.  The multi-center study is proposed to be conducted at 5 centres across India in about 68 patients.  The study duration will be approximately 18 months which include screening and enrollment phase and treatment phase. For each participant the duration of the study will be approximately 5 months (20 weeks). No formal sample size calculation will be performed. 68 patients will be enrolled in the study and will be equally distributed in both cohorts in 1:1 ratio. Descriptive statistics (n, mean, SD, Median, Minimum, and Maximum) will be calculated for continuous data. Categorical data will be depicted with count (%).

  
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