| CTRI Number |
CTRI/2024/09/073550 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
12/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian Population |
|
Scientific Title of Study
|
A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian Population |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BIO/CT18/FF/2022/34947 |
Other |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRADEEP KUMAR |
| Designation |
Professor |
| Affiliation |
Army Hospital RESEARCH AND REFERRAL |
| Address |
OPHTHALMOLOGY DEPARTMENT ARMY HOSPITAL RESEARCH AND REFERRAL ,NEW DELHI
South West
DELHI
110010
India |
| Phone |
09560034515 |
| Fax |
|
| Email |
pradeepthakurella@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrida Dutt |
| Designation |
Resident |
| Affiliation |
Army Hospital Research And Referral New Delhi |
| Address |
Ophthalmology Department 1ST Floor Army Hospital Research And Referral New Delhi
South West
DELHI
110010
India |
| Phone |
07292047066 |
| Fax |
|
| Email |
mridasharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRADEEP KUMAR |
| Designation |
Professor |
| Affiliation |
ARMY HOSPITAL RESEARCH AND REFERRAL NEW DELHI |
| Address |
OPHTHALMOLOGY DEPARTMENT ARMY HOSPITAL RESEARCH AND REFERRAL ,NEW DELHI
South West
DELHI
110010
India |
| Phone |
9560034515 |
| Fax |
|
| Email |
pradeepthakurella@yahoo.com |
|
|
Source of Monetary or Material Support
|
| The trial will be conducted with monetary/material support from Army Hospital research and referral |
|
|
Primary Sponsor
|
| Name |
Army Hospital Research And Referral |
| Address |
Army Hospital Research And Referral, Delhi Cantt 110010 |
| 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 LT COL PRADEEP KUMAR |
Army Hospital Research And Referral New Delhi |
Ophthalmology Department Room no 2, 1 st Floor Army Hospital Research And Referral New Delhi PIN CODE 110010 INDIA
South West
DELHI |
9560034515
pradeepthakurella@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AFLIBERCEPT |
INTRAVITREAL AFLIBERCEPT 2.0 MG.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 by assessing BCVA, CMT on OCT Macula,OCTA and any adverse effects at 4 weekly interval till 48 weeks. |
| Intervention |
FARICIMAB |
INTRAVITREAL FARICIMAB 6.0 MG TO BE ADMINISTERED . 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 by assessing
BCVA, CMT on OCT Macula,OCTA and any adverse effects at 4 weekly interval till 48 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above
Piagnosed with Diabetic Macular Edema
Patients willing to participate in study.
|
|
| ExclusionCriteria |
| Details |
Patients with other retinal diseases
decreased visual acuity due to causes other than macular edema
macular edema due to causes other than diabetes mellitus
any form of central cataract in phakic patients
posterior capsular opacity/iol subluxation in pseudophakic patients
history of any uveitis, pregnant and lactating females. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of intravitreal faricimab 6.0mg vs aflibercept 2.0 mg in diabetic macular edema in Indian population |
follow up at zero week, then 4 week then every 4 weekly till 48 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare efficacy of faricimab vs aflibercept in improving BCVA, reduction in Central macular thickness and inter injection interval . |
follow up at zero week, then 4 week then every 4 weekly till 48 weeks. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
Final Enrollment numbers achieved (Total)= "74"
Final Enrollment numbers achieved (India)="74" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/09/2024 |
| Date of Study Completion (India) |
30/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
It will be a Randomised Controlled Study. The Study will be carried out at Department of Ophthalmology ,Army Hospital Research and Referral New Delhi . The study Population will be patients diagnosed with Diabetic Macular Edema . Diabetic Macular Edema stands as a significant Sight-Threatening complication of Diabetic Retinopathy, contributing substancially to the global burden of visual impairment. The aim of this study is to compare the Efficacy of Intravitreal Faricimab 6.0MG And Aflibercept 2.0MG in Treatment Naive Diabetic Macular Edema by observing the improvement in Best corrected Visual Acuity , reduction in Central Macular Thickness and to study whether Faricimab is able to achieve Longer Inter-injection Interval.Patients will be examined at 0,4 and 8 weeks and all patients meeting the inclusion criteria will receive loading doses as per the group in which they are assigned and will be followed up at 4 weekly interval. Decision for Retreatment will be taken after 4 weeks of injection on the basis of worsening of Visual Acuity and Increase in Central Macular Thickness. |