| CTRI Number |
CTRI/2022/01/039718 [Registered on: 25/01/2022] Trial Registered Prospectively |
| Last Modified On: |
05/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the safety and effectiveness of intravitreal injections of brolucizumab in patients with neovascular age-related macular degeneration |
|
Scientific Title of Study
|
A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with neovascular age-related macular degeneration (nAMD) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CRTH258AIN01 version 0.2 dated 06-May-2021 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr. Anup Thorat |
| Designation |
Franchise Medical Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited.
The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
anup_vilas.thorat@novartis.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr. Anup Thorat |
| Designation |
Franchise Medical Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited.
The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
anup_vilas.thorat@novartis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr. Anup Thorat |
| Designation |
Franchise Medical Head |
| Affiliation |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited.
The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East
Mumbai
MAHARASHTRA
400051
India
Mumbai
MAHARASHTRA
400051
India |
| Phone |
|
| Fax |
|
| Email |
anup_vilas.thorat@novartis.com |
|
|
Source of Monetary or Material Support
|
| Novartis Healthcare Private Limited |
|
|
Primary Sponsor
|
| Name |
Novartis Healthcare Private Limited |
| Address |
Novartis Healthcare Private Limited.
The Inspire – BKC, 7th Floor, G-Block,
BKC Main Road, Bandra Kurla Complex, Bandra East, Mumbai,
Maharastra- 400051 India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rohan Chawla |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES,
Room No lO2, lst Floor Old O.T. Block,
Ansari NAGAR, NEW DELHI 11OO29
New Delhi
DELHI |
011-26588500
dr.rohanrpc@gmail.com |
| Dr Debdulal Chakraborty |
Disha Eye Hospitals Pvt. Ltd. |
Disha Eye Hospitals Pvt. Ltd.
14, Grand Trunk Road, Sheoraphuli,
West Bengal, Hooghly, Pin: 712223
Hugli
WEST BENGAL |
9433059923
devdc@rediffmail.com |
| Dr N Padma Preetha |
Dr. Agarwal s Eye Hospital Ltd |
Dr. Agarwals Eye Hospital Ltd,
222 TTK Road, Alwarpet, Chennai-600018
Tamil Nadu, India.
Chennai
TAMIL NADU |
9994954336
tgpreetha@gmail.com |
| Dr Sonali Shah |
Government Eye Hospital |
Government Eye Hospital,
M&J Institute of
Ophthalmology, Director office
Manjushri Mill compound,
Asarwa, Ahmedabad 380016.
Ahmadabad
GUJARAT |
9825349361
sonali00shah@rediffmail.com |
| Dr Vishal Raval |
L V Prasad Eye Institute |
L V Prasad Eye Institute
Kallam Anji Reddy Campus
L V.Prasad Marg, Banjara Hills
Hyderabad - 500 034 Telangana, India
Hyderabad
TELANGANA |
8374588011
drvishalraval@gmail.com |
| Dr Ramesh Venkatesh |
Narayana Nethralaya |
Narayana Nethralaya,
121/C, Chord Road, 1 st R
Block Rajaji Nagar,
Bangalore, Karnataka-560010
Bangalore
KARNATAKA |
91-44-28271616
vramesh80@yahoo.com |
| Dr Simar Rajan |
Post Graduate Institute of Medical Education and Research |
Advance Eye Center, Post Graduate Institute of Medical Education and Research,
Chandigarh 160012.
Chandigarh
CHANDIGARH |
9914427851
simarrajansingh@gmail.com |
| DrAtul Kumar Sahu |
R.K.Netralaya Eye Hospital Pvt. Ltd |
R.K.Netralaya Eye Hospital Pvt. Ltd.
D-63/10 B-lA, Dayal Enclave
Mahmoorganj, Varanasi-221010
Uttar Pradesh
Varanasi
UTTAR PRADESH |
8808069458
atulkrsahu@gmail.com |
| Dr Aditya Sudhalkar |
Raghudeep Eye Hospital |
Raghudeep Eye Hospital Nr.
Shreeji Complex Gurukul road,
Memnagar, Ahmedabad,
380052 Gujarat, India
Ahmadabad
GUJARAT |
9909917561
adityasudhalkar@yahoo.com |
| Dr Asim Kumar Ghosh |
Regional Institute of Ophthalmology |
Regional Institute of Ophthalmology, medical College & hospital, 88, College street. Kolkata- 700073.
West Bengal. India.
Kolkata
WEST BENGAL |
8240895240
akghosheye@gmail.com |
| DrPramod Sadashiorao Bhende |
Sankara Nethralaya{A Unit of Medical Research Foundation) |
Sankara Nethralaya{A Unit of Medical Research Foundation)
41/18.College Road, Nungambakkam,
Chennai-600006.Tamil Nadu
Chennai
TAMIL NADU |
91-44-28271616
drpb@snmail.org |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Disha Eye Hospitals Pvt. Ltd. Ethics Committee |
Approved |
| Dr. Agarwal s Hospital Institutional Ethics Committee |
Approved |
| Dr. Rohan Chawla-Institutional Ethics Committee |
Approved |
| G.V.Meditech Ethics Committee |
Approved |
| Iladevi Cataract & IOL Research Centre Ethics Committee |
Approved |
| Institutional Ethics Committee- Post Graduate institute of Medical Education and Research |
Approved |
| Institutional Review Board (Ethics Committee) of Vision Research Foundation |
Approved |
| L V Prasad Eye lns!itute-Ethics Committee |
Approved |
| Narayana Nethralaya Ethics Committee |
Approved |
| Regional institute of Ophthalmology-lnstitutional Ethics Committee |
Approved |
| Rogi Kalyan Samiti |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H578||Other specified disorders of eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Brolucizumab Injection (120mg/ml) |
A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with neovascular age-related macular degeneration (nAMD)
Dose: 6 mg injection
Frequency: Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.
Patients who are scheduled for q8w dosing with brolucizumab will receive injections at weeks 16, 24, 32, 40, 48.
Patients who are scheduled for q12w dosing of brolucizumab will receive injections at weeks 20, 32, and 44
route of administration: intravenous (IV)
duration of therapy: 56 week study |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Female or male, treatment naïve patient with ≥50 years of age, with neovascular age-related macular degeneration (nAMD).
Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
Note: In case where both eyes are affected, data of only one eye [‘study eye’] will be recorded. selection of the eye to be considered for the purpose of the study [referred to as ‘study eye’] will be as per the Investigator’s discretion. |
|
| ExclusionCriteria |
| Details |
Patient having other eye diseases that could compromise the visual acuity (VA).
Patient with existing or suspected ocular or periocular infection in the study eye.
Patient with an existing intraocular inflammation (IOI).
Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator’s judgment.
Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study.
Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence and characteristics of treatment-emergent adverse events |
baseline to Week 56. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA) |
baseline to Week 56. |
| Characterize the number of anti-VEGF injections, number of non-injection visits, and total number of visits |
baseline to Week 56. |
| Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12w |
baseline to Week 56. |
| Estimate effect of brolucizumab on fluid |
baseline to week 16 and week 56. |
| Estimate effect of brolucizumab on central subfield thickness (CST) |
baseline to week 16 and week 56. |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
Final Enrollment numbers achieved (Total)= "105"
Final Enrollment numbers achieved (India)="105" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2022 |
| Date of Study Completion (India) |
05/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Age-related macular degeneration (AMD) is the leading cause of severe vision loss in people affecting 10%-13% of individuals over the age of 65 in North America, Europe, and Australia . Genetic, environmental, and health factors play an important role in the pathogenesis of the disease. The purpose of this study is to generate additional safety and effectiveness data in a larger nAMD patient population in India that more closely resembles the real-world population intended to be treated with brolucizumab. A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI) of brolucizumab in patients with neovascular age-related macular degeneration (nAMD) |