| CTRI Number |
CTRI/2024/11/077182 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
18/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Intravitreal Faricimab and Aflibercept in nAMD in Indian population |
|
Scientific Title of Study
|
Prospective comparative trial of efficacy of faricimab 6.0 mg vs aflibercept 2.0 mg in neovascular age related macular degeneration in indian population |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sqn Ldr Shailaza Tripathi |
| Designation |
Resident Ophthalmology |
| Affiliation |
Army Hospital Research and Referral Delhi |
| Address |
Dept of Ophthalmology Army Hospital Research and Referral Delhi
New Delhi
DELHI
110010
India |
| Phone |
7863085904 |
| Fax |
|
| Email |
Drshailazaafmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S K Mishra |
| Designation |
Prof & HOD Ophthalmology |
| Affiliation |
Army Hospital Research and Referral Delhi |
| Address |
Dept of Ophthalmology Army Hospital Research and Referral Delhi
New Delhi
DELHI
110010
India |
| Phone |
9811551327 |
| Fax |
|
| Email |
sanjusonu_2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Sqn Ldr Shailaza Tripathi |
| Designation |
Resident Ophthalmology |
| Affiliation |
Army Hospital Research and Referral Delhi |
| Address |
Dept of Ophthalmology Army Hospital Research and Referral Delhi
New Delhi
DELHI
110010
India |
| Phone |
7863085904 |
| Fax |
|
| Email |
Drshailazaafmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army hospital research and referral, Delhi cantt |
|
|
Primary Sponsor
|
| Name |
Army hospital research and referral Delhi cantt |
| Address |
Dept of ophthalmology
Army hospital research and referral
Delhi cantt |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr S K Mishra |
Army hospital research and referral |
room no 1 Dept Of Ophthalmology and advanced visual sciences
Delhi cantt
New Delhi
DELHI |
9811551327
sanjusonu_2000@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee army hospital research and referral delhi cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
aflibercept |
2 mg intravitreal 4 weekly for 78 weeks |
| Intervention |
Faricimab |
6 mg intravitreal 4 weekly for 78 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
BCVA LESS THAN 6/6 IN AFFECTED EYE
NEOVASCULAR AMD ON OCT MACULA SRF/IRF |
|
| ExclusionCriteria |
| Details |
History of any form of uvietis
History of systemic vasculitis
Coexisting ocular or retinal morbidity other than nAMD
Any form of central cataract in phakic patients
Any posterior capsular opacification or IOL subluxation in pseudophakic patients
Pregnancy
Systemic contraindications to anti vegf therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare faricimab and aflibercept to treat neovascular age related macular degeneration using differences in mean best visual acuity after six months in two groups |
baseline and at the end of 4 weeks then 8 weeks then 12 weeks till 78 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to determine the number of patients maintaining q12 weeks dosing interval of faricimab at the end of 78 weeks.
to determine the risk of adverse drug reactions with faricimab whenn compared with aflibercept |
baseline, 4 weeks, 8 weeks,12 weeks then 12 weekly till 78 weeks |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/11/2024 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Neovascular Age-related macular degeneration (AMD) encompasses progressive retinal degenerative changes affecting the macula and hence affecting central vision. It affects mainly the aged population. None of the currently available treatments cures or reverses the disease. Introduction of Anti- VEGF for its treatment has led to therapeutic advancement in managing nAMD. Introduction of Faricimab offers a possible hope of achieving of q12weeks - q16 weeks goals in almost half of the population as evidenced in the STAIRWAY phase 2 and phase 3. However, these trials were conducted on patients outside India. Faricimab is a bispecific antibody which targets both Ang-2 and vascular endothelial growth factor-A (VEGF-A) hence sustained efficacy for longer treatment intervals for age related macular degeneration. Our study encompasses intravitreal injection either Faricimab 6.0 mg or Aflibercept 2.0 mg intravitreal in the affected eye under topical anaesthesia under asepsis after taking informed consent. Patients will be examined at 0, 4 & 8 weeks and all patients will receive 3 four-weekly loading dose. Following this all patients would be examined at 4 weekly intervals for disease activity assessment. Disease activity will be monitored and at the end we shall be comparing the results of the two arms of the study. |