| CTRI Number |
CTRI/2023/09/058134 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
27/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of two different intraocular injections in diabetic related retinal disease |
|
Scientific Title of Study
|
Study to assess the efficacy and safety of brolucizumab and aflibercept in patients with visual impairment due to dme- a randomised clinical trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satyaki Mondal |
| Designation |
Ophthalmology resident |
| Affiliation |
Command Hospital, Eastern Command |
| Address |
Department of Ophthalmology, Kolkata Command Hospital, New alipore,Kolkata 27
Kolkata
WEST BENGAL
700027
India |
| Phone |
7319342492 |
| Fax |
|
| Email |
satyaki.mondal10@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Lt Col Vipin Rana |
| Designation |
Associate professor |
| Affiliation |
Command Hospital, Eastern Command |
| Address |
Department of Ophthalmology, Kolkata Command Hospital, New alipore,Kolkata 27
Kolkata
WEST BENGAL
700027
India |
| Phone |
6284795039 |
| Fax |
|
| Email |
arv_198290@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Satyaki Mondal |
| Designation |
Ophthalmology resident |
| Affiliation |
Command Hospital, Eastern Command |
| Address |
Department of Ophthalmology, Kolkata Command Hospital, New alipore,Kolkata 27
Kolkata
WEST BENGAL
700027
India |
| Phone |
7319342492 |
| Fax |
|
| Email |
satyaki.mondal10@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Vipin Rana |
| Address |
Department of Ophthalmology, Kolkata Command Hospital,new alipore, Kolkata 27 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Satyaki Mondal |
Command Hospital, Eastern Command |
Department of Ophthalmology, VR Clinic: Room no.4
Kolkata
WEST BENGAL |
7319342492
satyaki.mondal10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Command Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intravitreal injection aflibercept |
2 mg in 0.05 ml intravitreal route as per requirement functional and anatomical outcomes measured were mean changes in BCVA, CMT, presence of intraretinal fluid and subretinal fluid by SD OCT, on POD 1 and after 4 week, 8th week,12th week then 6 weekly. |
| Intervention |
Intravitreal injection brlolucizumab |
6mg in .0.05 ml in intravitreal route asper required on functional and anatomical outcomes measure subretinal fluid by SD OCT, on POD 1 and after 4 week, 8th week,12th week then 6 weekly. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female patients >18 years old with visual impairment due to DME.
2. Patients with type 1 or type 2 diabetes mellitus and Hba1c of <10% at screening.
3. Patient or legally acceptable representative willing to voluntarily provide signed informed consent for participation in the study. |
|
| ExclusionCriteria |
| Details |
1. Patient with existing or suspected ocular or periocular infection in the study eye.
2. Patient with uncontrolled glaucoma defined as intraocular pressure >25 mmhg despite treatment with antiglaucoma medication, or according to investigators judgement.
3. Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
4. Active proliferative diabetic retinopathy in the study eye as per investigator.
5. Previous treatment with any anti-vegf drugs or investigational drugs in the study eye.
6.Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 month period prior to baseline.
7. Intraocular surgery including YAG laser in the study eye during the 3 month period prior to baseline.
8. Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Non-inferiority of brolucizumab to aflibercept with respect to change in visual acuity from baseline upto week24 |
1 year 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To characterize the number of anti-VEGF injections, non-injection visits,and total number of visits during the study, to evaluate the effectiveness of brolucizumab on fluid(IRF,SRF) from baseline to 4th week 8th week,12th week & 24 th week to evaluate the effectiveness of brolucizumab on central retinal thickness from baseline to week 24 |
1year 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
17/10/2023 |
| Date of Study Completion (India) |
01/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
No inferiority of brlolucizumab to aflibercept to the change visual acuity from baseline upto week 24. Intravitreal anti-VEGF injections remain the gold standard for management of chorioretinal vascular disease including AMD, DME,RVO. |