| CTRI Number |
CTRI/2025/04/085831 [Registered on: 28/04/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To test the effectiveness and safety of sponsor product of Intravitreal OTX-TKI (Axitinib Implant) in cases of Neovascular Age- Related Macular Degeneration |
|
Scientific Title of Study
|
A Phase 3, Multicenter, Double-Masked, Randomized, Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Axitinib Implant) in Subjects with Neovascular Age- Related Macular Degeneration |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| OTX-TKI-2023-AMD-303 Version 4.0 dated 20Nov2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurendra Das |
| Designation |
Executive Director |
| Affiliation |
PFC Pharma Focus India Pvt Ltd |
| Address |
Unit 306 2nd Floor
1094p Arya Samaj Road
Sector 46 Gurgaon
Gurgaon
HARYANA
122018
India |
| Phone |
9971099950 |
| Fax |
|
| Email |
sauren@pfcpharma.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Saurendra Das |
| Designation |
Executive Director |
| Affiliation |
PFC Pharma Focus India Pvt Ltd |
| Address |
Unit 306 2nd Floor
1094p Arya Samaj Road
Sector 46 Gurgaon
Gurgaon
HARYANA
122018
India |
| Phone |
9971099950 |
| Fax |
|
| Email |
sauren@pfcpharma.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurendra Das |
| Designation |
Executive Director |
| Affiliation |
PFC Pharma Focus India Pvt Ltd |
| Address |
Unit 306 2nd Floor
1094p Arya Samaj Road
Sector 46 Gurgaon
Gurgaon
HARYANA
122018
India |
| Phone |
9971099950 |
| Fax |
|
| Email |
sauren@pfcpharma.com |
|
|
Source of Monetary or Material Support
|
| Ocular Therapeutix, Inc.
15, Crosby Drive, Bedford, MA 01730 USA |
|
|
Primary Sponsor
|
| Name |
Ocular Therapeutix, Inc. |
| Address |
15 Crosby Drive Bedford, MA 01730 USA |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| PFC Pharma Focus India Pvt Ltd |
PFC Pharma Focus India Pvt Ltd , Plot No. 121, Basement Pocket - 1, Jasola, New Delhi - 110025 |
|
|
Countries of Recruitment
|
Argentina
Australia
Czech Republic
Finland
Germany
Hungary
India
Italy
Poland
Spain
United States of America |
|
Sites of Study
|
| No of Sites = 20 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ruchiben Kiritkumar Mehta |
Advanced Retina Care |
Cross Road BRTS Stop, 404, 405, AAGAM Avenue Near Adani Gas Station and AAGAM flats On Sabarmati, Visat Road, Opp. Motera, Motera, Ahmedabad, Gujarat - 380005
Ahmadabad
GUJARAT |
9313587736
drruchimehta2012@gmail.com |
| Dr Vishal Agrawal |
Agrawal Hospital |
Malviya Industrial Area, Jaipur, Rajasthan - 302017
Jaipur
RAJASTHAN |
9024472330
drvishalsms@gmail.com |
| Dr Naresh Babu Kannan |
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology |
No. 1 Anna Nagar, Madurai, Tamil Nadu - 625020
Madurai
TAMIL NADU |
0452 4356100
cauveryeye@gmail.com |
| Dr George J Manayath |
Aravind Eye Hospital, Coimbatore |
Avinashi Road,Coimbatore, Tamil Nadu - 641014
Coimbatore
TAMIL NADU |
0422-4360400
gjmanayath@gmail.com |
| Dr Nilesh Balaji Giri |
Dr D Y Patil Medical College, Hospital & Research Centre |
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra - 411018
Pune
MAHARASHTRA |
9284528896
nilesh.giri@dpu.edu.in |
| Dr Pradeep Venkatesh |
Dr. Rajendra Prasad Centre For Ophthalmic Sciences, All India Institute of Medical Sciences |
Dr. Rajendra Prasad Centre For Ophthalmic Sciences, All India Institute of Medical Sciences, Ansari Nagar, New Delhi - 110029
New Delhi
DELHI |
011-26593012
venkyprao@yahoo.com |
| Dr Manisha Agarwal |
Dr. Shroffs Charity Eye Hospital |
5027, Kedarnath Road Daryaganj, New Delhi 110002
New Delhi
DELHI |
011-43524444
manisha@sceh.net |
| Dr Jignesh Gosai |
Government Eye Hospital (M & J Institute of Ophthalmology) |
Room No. - 268, Manjushree Mill Compund, Badiya Limdi Cross Road, Asarwa, Ahmedabad Gujarat - 382424
Ahmadabad
GUJARAT |
9824321195
dr_jigneshgosai@hotmail.com |
| Dr Shahana Mazumdar |
ICARE Eye Hospital & Post Graduate Institute |
E-3A, Sector 26, Noida, Uttar Pradesh - 201301
Gautam Buddha Nagar
UTTAR PRADESH |
9818575883
shahana.mazumdar@gmail.com |
| Dr Sanghamitra Kanungo |
Kar Vision Eye Hospital |
10, Satyanagar, Janpath, Bhubaneswar, Odisha - 751007
Khordha
ORISSA |
9437002130
drskanungo@gmail.com |
| Dr Umesh Chandra Behera |
L V Prasad Eye Institute, Bhubaneswar |
MTC Campus, Patia, Bhubaneswar, Odisha - 751024
Khordha
ORISSA |
0674-2653108
umesh@lvpei.org |
| Dr Ritesh Narula |
L V Prasad Eye Institute, Hyderabad |
Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Road No 2, Hyderabad, Telangana - 500034
Hyderabad
TELANGANA |
040-68102123
ritesh.narula@lvpei.org |
| Dr Naresh Kumar Yadav |
Narayana Nethralaya |
#121/C Chord Road, 1st ‘R’ Block, Rajaji Nagar, Bengaluru, Karnataka - 560010
Bangalore
KARNATAKA |
080-66121463
vasudhanaresh@gmail.com |
| Dr Sucheta Kulkarni |
PBMAs H V Desai Eye Hospital |
93, Tarawade Vasti, Mohammadwadi, Hadapsar, Pune, Maharashtra - 411060
Pune
MAHARASHTRA |
020-26974000
sucheta.kulkarni@hvdeh.org |
| Dr Rajesh Ramanjulu |
Sankara Eye Hospital, Bengaluru |
Varthur Main Road, Kundalahalli Gate, Bengaluru, Karnataka - 560037
Bangalore
KARNATAKA |
080-6903 8900
drragraj@gmail.com |
| Dr Prabhu Shanker M |
Sankara Eye Hospital, Coimbatore |
Sathy Main Road, Sivananda Puram, Coimbatore, Tamil Nadu - 641035
Coimbatore
TAMIL NADU |
0422-425 6789
prabhu@sankaraeye.com |
| Dr Muna Bhende |
Sankara Nethralaya, Medical Research Foundation |
Padmabhusan Dr.S.S.Badrinath Campus, 41/18, College Road, Nungambakkam, Chennai, Tamil Nadu - 600006
Chennai
TAMIL NADU |
04428271616
drmuna@smail.com |
| Dr Rahul Shroff |
Shroff Eye Hospital Vision Research Centre |
222, S V Road, Bandra (west), Mumbai Maharashtra 400050
Mumbai
MAHARASHTRA |
022 6692 1000
rahul@shroffeye.org |
| Dr Sandeep Parwal |
SMS Medical College and attached Hospital |
Jawahar Lal Nehru Marg, Ashok Nagar, Jaipur, Rajasthan - 302004
Jaipur
RAJASTHAN |
0141 2621315
sandeepparwal1983@gmail.com |
| Dr Jatinder Singh |
The Eye Foundation |
582-A, DB Road, RS Puram, Coimbatore, Tamil Nadu - 641002
Coimbatore
TAMIL NADU |
0422-4242000
drjati@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 20 |
| Name of Committee |
Approval Status |
| Dr. Shroffs Charity Eye Hospital Ethics Committee |
Approved |
| Ethics Committee, Dr. D.Y. Patil Vidyapeeth Pune |
Submittted/Under Review |
| ICARE Eye Hospital and PGI Ethics Committee |
Approved |
| IEC Aravind Eye Hospital Madurai |
Submittted/Under Review |
| Institutional Ethics Committee |
Approved |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee |
Submittted/Under Review |
| Institutional Ethics Committee of PBMas H. V. Desai Eye Hospital |
Approved |
| Institutional Ethics Committee, AIIMS |
Submittted/Under Review |
| Institutional Ethics Committee, BJ Medical College & Civil Hospital |
Submittted/Under Review |
| Institutional Human Ethics Committee |
Submittted/Under Review |
| Institutional Review Board-Ethics Committee |
Approved |
| Kar Vision Institutional Ethics Committee |
Approved |
| L V Prasad Eye Institute Ethics Committee |
Approved |
| Narayana Nethralaya Ethics Committte |
Approved |
| Riddhi Medical Nursing Home IEC |
Submittted/Under Review |
| SMS Medical College and Attached Hospital |
Submittted/Under Review |
| Somani Hospital EC |
Submittted/Under Review |
| The Eye Foundation Ethics Committee |
Approved |
| The Shroff Eye Hospital Ethics Committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eylea |
Eylea 2 mg intravitreal (ophthalmic) injection given every month |
| Intervention |
OTX-TKI |
Axitinib Intravitreal (ophthalmic) Implant to be used every 6 months |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with a diagnosis of active macular choroidal neovascularization (MNV)
secondary to nAMD, who are at least 50 years of age, whose study eye either is
treatment naive, or was diagnosed with nAMD within 4 months prior to screening
and received 1 to 3 consecutive monthly (approximately every 4 weeks) anti-VEGF
injections (except Beovu®) prior to Screening |
|
| ExclusionCriteria |
| Details |
Presence of a disease other than CNV due to AMD in the study eye that could affect vision or safety assessments |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in best corrected visual acuity (BCVA) |
Change from baseline to Week 48 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in letters on ETDRS at Week 48 |
Week 48 |
|
|
Target Sample Size
|
Total Sample Size="825"
Sample Size from India="250"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
09/05/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
24/12/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- 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 - Proposals should be directed to [sauren@pfcpharma.com].
- For how long will this data be available start date provided 01-04-2028 and end date provided 31-03-2030?
Response (Others) - Yet to be decided
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study consists of a 24-week screening and run-in period prior to Day 1, followed by an active study treatment period from Day 1 to Week 40 (Visit 17), with a follow-up period through Week 48 (Visit 19). The primary analysis is at Week 48. |