| CTRI Number |
CTRI/2021/06/034415 [Registered on: 28/06/2021] Trial Registered Prospectively |
| Last Modified On: |
25/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A CLINICAL TRIAL TO STUDY THE EFFICACY OF TWO DRUGS, BROLUCIZUMAB AND AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE RELATED MACULAR DEGENERATION IN INDIAN POPULATION |
|
Scientific Title of Study
|
A PROSPECTIVE COMPARATIVE LONGITUDINAL STUDY OF EFFICACY OF BROLUCIZUMAB 6.0 MG VERSUS AFLIBERCEPT 2.0 MG IN NEOVASCULAR AGE RELATED MACULAR DEGENERATION IN INDIAN POPULATION |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Srishti Khullar |
| Designation |
Resident -Ophthalmology |
| Affiliation |
Army Hospital Research And Referral |
| Address |
Department of Ophthalmology, Army Hospital ,Research and Referral, Dhaula Kuan
SEC-14
South
DELHI
110010
India |
| Phone |
07478179087 |
| Fax |
|
| Email |
srishtikhullar24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Mishra |
| Designation |
Professor and HOD |
| Affiliation |
Army Hospital Research And Referral |
| Address |
Department of Ophthalmology, Army Hospital, Research and Referral, Dhaula Kuan
South West
DELHI
110010
India |
| Phone |
9811551327 |
| Fax |
|
| Email |
sanjusonu_2000@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srishti Khullar |
| Designation |
Resident -Ophthalmology |
| Affiliation |
Army Hospital Research And Referral |
| Address |
Department of Ophthalmology,Army Hospital, Research and referral, Dhaula Kuan
SEC-14
South West
DELHI
110010
India |
| Phone |
07478179087 |
| Fax |
|
| Email |
srishtikhullar24@gmail.com |
|
|
Source of Monetary or Material Support
|
| ARMY HOSPITAL, RESEARCH AND REFERRAL ,DELHI |
|
|
Primary Sponsor
|
| Name |
Army Hospital Research and ReferralDelhi |
| Address |
Army Hospital,Research and Referral |
| Type of Sponsor |
Government medical college |
|
|
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 Srishti Khullar |
Army Hospital,Research and Referral |
Department of Ophthalmology, Army Hospital, Research and Referral Dhaula Kuan
South West
DELHI |
7478179087
srishtikhullar24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE,ARMY HOSPITAL (R&R),DELHI CANTT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
AFLIBERCEPT 2.0 MG |
ADMINISTRED INTRAVITREALLY AFLIBERCEPT 2.0 MG IN AFFECTED EYE.TREATMENT CONSISTS OF THREE LOADING DOSES AT MONTHLY INTERVAL(0,4 AND 8 WEEKS) FOLLOWING WHICH ALL PATIENTS WILL BE EXAMINED AT 4 WEEKLY INTERVAL FOR RE-INJECTION.TOTAL DURATION OF FOLLOW UP WILL BE 36 WEEKS. RE-INJECTION WILL BE BASED ON REDEVELOPMENT OF SRF AND FALL IN VISUAL ACUITY |
| Intervention |
BROLUCIZUMAB 6.0 MG |
ADMINISTRED INTRAVITREALLY BROLUCIZUMAB 6.0 MG IN AFFECTED EYE.TREATMENT CONSISTS OF THREE LOADING DOSES AT MONTHLY INTERVAL(0,4 AND 8 WEEKS) FOLLOWING WHICH ALL PATIENTS WILL BE EXAMINED AT 4 WEEKLY INTERVAL FOR RE-INJECTION.TOTAL DURATION OF FOLLOW UP WILL BE 36 WEEKS.RE-INJECTION WILL BE BASED ON REDEVELOPMENT OF SRF AND FALL IN VISUAL ACUITY ON CASE TO CASE BASIS |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
a. Typical morphology of Age-Related Macular Degeneration
b. Lesion affecting the central subfield (1 mm around centre)
c. Active Choroidal Neovascularization
d. CNV comprising more than 50% of total lesion area
e. Intraretinal or Subretinal Fluid in central subfield
f. BCVA between 20/32 to 20/400
|
|
| ExclusionCriteria |
| Details |
a. Any Fibrosis or geographical atrophy of central subfield
b. Any intra or periocular infection or inflammation
c. Patient has received any approved treatment for nAMD other than micronutrient supplementation
d. Any concurrent intraocular disease like diabetic retinopathy
e. History of drug sensitivity/ Allergic reactions to research interventions
f. Stroke or MI in the 90 days preceding to baseline visit
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To establish non-inferiority of Brolucizumab as compared to Aflibercept in terms of best corrected visual acuity from baseline to 36 weeks |
At the end of 36 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the number of patients maintaining q12weeks dosing interval of Brolucizumab
|
At the end of 36 weeks |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/07/2021 |
| Date of Study Completion (India) |
28/02/2022 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response (Others) - Data will be made available post publication.
- For how long will this data be available start date provided 31-03-2022 and end date provided 31-03-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
The duration of action of currently accepted first line treatment for neovascular age related macular degeneration is Ranibizumab and Aflibercept. The duration of action of Ranibizumab being 4 weeks and Aflibercept being 8 weeks. This creates a recurrent requirement of four weekly evaluation of patient leading to immense logistical and financial burden on patients. This study aims to compare Brolucizumab with Aflibercept in patients with neovascular age related macular degeneration in Indian population. Brolucizumab is a new molecule and is a longer acting drug. Brolucizumab offers a possibility of increasing the duration between hospital visits in patients of neovascular age related macular degeneration. |