| CTRI Number |
CTRI/2025/06/089348 [Registered on: 23/06/2025] Trial Registered Prospectively |
| Last Modified On: |
03/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Study to assess the safety , tolerability and effectiveness of Ranibizumab Injection for treating Retinopathy of Prematurity in preterm infants. |
|
Scientific Title of Study
|
A multicentre, open-label, prospective, single-arm, non-comparative, non-randomized phase IV study to evaluate safety and efficacy of Injection Ranibizumab (of Sponsor Lupin Limited) given as intravitreal injection in preterm infants with Retinopathy of Prematurity |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 24-VIN-0299 V 02 Dated 29 Apr 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakesh Patel |
| Designation |
Head - Clinical Operations |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd.,
Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
8308843660 |
| Fax |
|
| Email |
Rakesh.Patel@veedalifesciences.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravi Alamchandani |
| Designation |
General Manager |
| Affiliation |
Veeda Clinical research Limited |
| Address |
Veeda Clinical Research Ltd.,
Shivalik Plaza, Near I.I.M.,Ambawadi, Ahmadabad
Ahmadabad
GUJARAT
380015
India |
| Phone |
9687306158 |
| Fax |
|
| Email |
Ravi.A1950@veedalifesciences.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Pramod V Kadam |
| Designation |
Manager - Medical Services |
| Affiliation |
Lupin Limited |
| Address |
3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai – 400055 Maharashtra, India
Mumbai
MAHARASHTRA
400055
India |
| Phone |
9011202149 |
| Fax |
|
| Email |
pramodvkadam@lupin.com |
|
|
Source of Monetary or Material Support
|
| Lupin Limited,
3rd Floor, Kalpataru Inspire, Off Western Express Highway,
Santacruz (East),
Mumbai – 400055
Maharashtra, India
|
|
|
Primary Sponsor
|
| Name |
Lupin Limited |
| Address |
3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai – 400055 Maharashtra, India |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Veeda Clinica lResearch Ltd |
Veeda Clinical Research Ltd., Shivalik Plaza, Near I.I.M.,
Ambawadi,
Ahmedabad –380015,
India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 8 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ratnesh Ranjan |
Drishtipunj Eye Hospital |
Department of Clinical Research,
North of Rupaspur Nahar Over bridge,
Beside Ishan International Girls School,
Vishwasharaiya Nagar,
Near Gola Road Petrol Pump,
Bailey Road, Patna, Bihar - 801503, India
Patna
BIHAR |
9566780877
drratneshranjan@gmail.com |
| Dr Snehal Bavaskar |
Narayana Netralaya |
121/C, 1st R Block, Rajajinagar, Banglore, Karnataka- 560010
Bangalore
KARNATAKA |
8686424238
snehal1128@gmail.com |
| Dr Sudipta Das |
Netralayam Superspeciality Eye Care Centre and BB Eye foundation |
Shree Tower II, RAA 36, Raghunathpur, VIP Road, Kolkata-700059
Kolkata
WEST BENGAL |
9331120224
drsudipta07@gmail.com |
| Dr Pekila Lama |
North Bengal Medical College and Hospital |
Department of Ophthalmology, Sushrutanagar,
Siliguri,
Darjeeling
West Bengal - 734012
Darjiling
WEST BENGAL |
9476154696
lamapekila@yahoo.com |
| Dr Manish Tandon |
Prayag Retina Care |
8/9/4 Panna Lal Road, Opp to D.R.T office, Prayagraj-211002
Allahabad
UTTAR PRADESH |
9364157694
drmanishtn@gmail.com |
| Dr Abhishek Anand |
Regional Institute of Ophthalmology Medical College & Hospital |
Department of Research, Indira Gandhi Institute of Medical sciences,
Sheikh pura ,
Patna - 800014
Patna
BIHAR |
8294777993
drabhishekrio@gmail.com |
| Dr Soumyadeep Majumdar |
Regional Institute of Ophthalmology Medical College & Hospital |
Department of Clinical Research,
Room no. 88,
College Street, Kolkata, 700073,
West Bengal, India.
Kolkata
WEST BENGAL |
9647683105
soumyanbmc@gmail.com |
| Dr Sharad Bhomaj |
Shanti Saroj Netralay |
Department of Clinical Research,
A.N Gaikwad, 901/902,
Beside Sundar Nagar,
Anand Nursing Home Road,
Off Sangli-Miraj Rd,
Maharstra-416410
Sangli
MAHARASHTRA |
9960516364
sharadbhomaj@reddifmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 8 |
| Name of Committee |
Approval Status |
| B B Eye Foundation VIP Ethics Committee |
Approved |
| IEC-Saishwari Clinic -Hospital for Mental Health |
Approved |
| Indira IVF Hospital Ethics Committee Prayagraj |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE ,BSL Eye care |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE for Human Research |
Approved |
| INSTITUTIONAL ETHICS COMMITTEE North Bengal Medical College And Hospital |
Approved |
| Institutional Ethics Committee, IGIMS |
Approved |
| Narayana Netralaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H351||Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ranibizumab (RaniEyes) 0.2 mg (0.02ml) intravitreal injection |
Dose Formulation: Ranibizumab Solution for injection
Dose Strength(s):0.2 mg (0.02 ml)
Dosage Level(s) :Single injection per eye
Route of Administration: Intravitreal Injection
Duration of Dose: Patient will be administered the study drug on Day 1 (Week 1) following which based on investigators discretion, study drug will be administered at an interval of 4 weeks. |
| Comparator Agent |
This is single arm study. Comparator agent is not applicable. |
This is single arm study. Comparator agent is not applicable. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1. Unilateral or Bilateral ROP with zone I (stage 1+, 2+, 3 or 3+), zone II (stage 3+) or AP-ROP (aggressive posterior ROP) disease.
2. Infants- Weighing less than 2000 grams or Infants less than 34 weeks of gestation
3. At baseline the weight of the infants should be more than or equal to 800 gm.
4. Informed consent provided by the parents or legal guardians of the patient for participation in the study.
|
|
| ExclusionCriteria |
| Details |
1. ROP disease characteristic in either eye other than that listed above at the time of the first dosing of the study drug.
2. A history of hypersensitivity (either the patient or the mother) to any of the excipients or active pharmaceutical ingredients or to drugs of similar chemical classes or any known allergies due to any drug or other allergies.
3. Had received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
4. Had been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during pregnancy)
5. Had used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever was longer
6. Had ocular structural abnormalities that were assessed by the Investigator to have had a clinically significant impact on study assessments
7. Had active ocular infection within 5 days before or on the day of first dosing or active or suspected ocular or periocular infection or active intraocular inflammation
8. Had a history of hydrocephalus requiring treatment
9. Had a history of any other neurological conditions that are assessed by the Investigator to have a significant risk of severe impact on visual function
10. Had any other medical conditions or clinically significant comorbidities or personal circumstances that were assessed by the Investigator to have a clinically relevant impact on study participation, any of the study procedures, or on efficacy assessments (e.g., poor life expectancy, pupil not able to be adequately dilated, unable to comply with the visit schedule)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the safety and tolerability of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity. |
safety assessment and Fundus examination will be performed on
Visit 3, Day 2 (week 1)
Visit 4, Day 8 (week 2)
Visit 5, Day 29 (week 5)
Visit 6, Day 57 (week 9) and
Visit 7, Day 85, (week 13)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Injection Ranibizumab (of Sponsor Lupin Limited) as intravitreal injection in preterm infants with Retinopathy of Prematurity. |
Efficacy will be assessed by
Evaluation of regression of proliferative phase and/or complete peripheral retinal vascularization by the investigator at visit 3, visit 4, visit 5, visit 6 & visit 7.
Number of infants without need for rescue treatment up to week 12 post first injection at visit 3, visit 4, visit 5, visit 6, & visit 7.
The number of re-injections of study dose required in the patient’s assessment of which will be done at visit 5, visit 6 & visit 7.
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 4 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="3" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This is a multicentre, open label, single arm, phase IV study to evaluate safety and efficacy of Ranibizumab given as intravitreal injection in preterm infants with Retinopathy of Prematurity. As per standard dosing regimen, Ranibizumab of Lupin Limited, 0.2 mg will be administered as a single intravitreal injection per eye to all eligible patients as per the eligibility criteria. Total duration of study will be approximately 93 days including the Screening period of 5 days, and treatment and assessment period of 85 days wherein, Screening will be done on Visit 1, Day -4 to Day 0 Dosing as single injection per day in the affected eye on Visit 2, Day 1 Note - As per investigator’s discretion, 2 additional injections or reinjection may be given with an interval of 4 weeks between 2 injections Safety Assessments and examinations on Day 2 , Day 8 , Day 29 and Day 5 EOS visit on Day 85 including all the end of the study safety assessments and study activities. |