CTRI/2025/03/081533 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On:
07/08/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
This is a single Group, Phase 3b, Open Label, Single-Arm Study to Investigate Usability and Safety of the Pre-filled Syringe Delivering 0.5 mg Intas- Ranibizumab in Participants with Neovascular Age-Related Macular Degeneration.
Scientific Title of Study
Single Group, Phase 3b, Open Label, Single-Arm Study to Investigate Usability and Safety of the Pre-filled Syringe Delivering 0.5 mg Intas- Ranibizumab in Participants with Neovascular Age-Related Macular Degeneration
Department of Clinical research, Room No. NA, Disha Eye Hospital Pvt. Ltd. 14, Grand Trunk Road, Sheoraphuli, West Bengal-712223.
Hugli WEST BENGAL
9433059923
devdc@rediffmail.com
Dr Satyaprakash Tiwari
Drishtipunj Eye Hospital Pvt. Ltd
Department of Clinical research, Room No. NA, Drishtipunj Eye Hospital Pvt. Ltd North of Rupaspur Nahar Over Bridge, Beside Ishan International Girls School, Vishwasharaiya Nagar, Near Gola Eoad Petrol Pump, Bailey Road Patna Bihar 801503
Patna BIHAR
9430857220
drsatyaprakashtiwary@gmail.com
Dr Bibhuti Kashyap
Kashyap Memorial Eye Hospital Pvt. Ltd.
Department of Clinical research, Room No. NA, Kashyap Memorial Eye Hospital Pvt. Ltd. Purulia Road, Near Dangratoli Chowk, Ranchi, Jharkhand 834001
Ranchi JHARKHAND
9811826765
drbibhutipkashyap@gmail.com
Dr Ashish Sharma
Lotus Eye hospital and institute
Department of Clinical
research, Room No.
NA, Lotus Eye Hospital and Institute Limited 770112, Avinashi Road, Civil Aerodrome Post -641014, India
Coimbatore TAMIL NADU
7339545781
drashish79@hotmail.com
DrSomesh Aggarwal
M & J Western Regional Institute of Ophthalmology
Department of Clinical research, Room No. NA, M & J Western Regional Institute of Ophthalmology, A unit of B.J Medical college and Civil hospital, Badiya Limbdi Char Rasta, New Civil Hospital Campus, Asarwa -380016, India.
Ahmadabad GUJARAT
9427029044
dr.somesh@yahoo.com
Dr Chaitra Jayadev
Narayana Nethralaya
Department of Clinical research, Room No. NA, Narayana Nethralaya, 121/C, Chord Road, 1st R Block Rajaji Nagar -560010
Bangalore KARNATAKA
Department of Clinical research, Room No. NA, Regional Institute of Ophthalmology, Medical college and hospital 88, College street, Kolkata 700073, West Bengal, India
Kolkata WEST BENGAL
9647683105
soumyanbmc@gmail.com
Dr Shobhana Mange
Shivam Retina Clinic and Eye Hospital.
Department of Clinical research, Room No. NA, Shivam Retina Clinic and Eye Hospital. HGI-A, I.T.C. Building, Majura Gate, Ring Road, Surat , Gujarat, India-395001
Surat GUJARAT
Disha Eye Hospitals Pvt. Ltd. Ethics Committee, Dr. Debdulal Chakraborty
Approved
Institutional Ethics committee for Human Reasearch, Dr. Ashish Sharma
Approved
Institutional Ethics committee, Ashwin Hospital, Dr. Soumyadeep Majumdar
Submittted/Under Review
Institutional Ethics Committee, B J Medical College and Civil Hospital, Dr. Somesh Vedprakesh Aggarwal
Approved
Institutional Ethics Committee,BSL Eye Care BSL EYE CARE, Dr. Satyaprakash Tiwari
Approved
Kashyap Memorial Eye hospital Ethics Committee KASHYAP MEMORIAL EYE HOSPITAL PVT. LTD, Dr. Bibhuti Kashyap
Approved
Narayana Nethralaya Ethics Committee, Dr. Chaitra Jayadev
Approved
PRANAV DIABETES CENTER ETHICS COMMITTEE, Dr. Sribhargava Natesh
Approved
UNITY HOSPITAL ETHICS COMMITTEE UNITY HOSPITAL ETHICS COMMITTEE, Dr. Shobhana Mange
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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
NA
NA
Intervention
Ranibizumab
Ranibizumab PFS delivering 0.5 mg ranibizumab for intravitreal
injection, Dose Formulation: Prefilled syringe (PFS), Dose: 0.5 mg is recommended once a month (approximately 28 days), Route of
Administration: Intravitreal Injection
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1) Participants must sign an ICF indicating that he/she understands the purpose of, and procedures
required for the study as described in the Informed consent process (Appendix 10.1.3) and in
this protocol and is willing to participate in the study.
2) Male or female greater than or equal to 18 years (completed years) of age at the time of signing the informed consent.
3) Participants who are eligible to receive treatment with IVT ranibizumab as per local prescribing
information based on independent judgement of retina specialist.
4) Participants who are currently already receiving IVT Lucentis/Accentrix treatment with at least 3 IVT injections completed.
5) Contraceptive use by participants should be consistent with local regulations regarding the
methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR • Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly
effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when
used consistently and correctly, as described in Appendix 4 during the intervention period
and for at least 45 days after the last dose of the study intervention. The investigator should
evaluate the effectiveness and the potential for contraceptive method failure (e.g.,
noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. • A WOCBP must have a negative test and test method should be a highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of the study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.3.
The investigator is responsible for review of medical history, menstrual history, and recent
sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy.
ExclusionCriteria
Details
1) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or
components/ excipients thereof (refer to the IB) or drug or other allergies that, in the opinion of
the investigator, contraindicate participation in the study.
2) Contraindications to the use of ranibizumab per local prescribing information.
3) Active or recent (within 4 weeks) intraocular inflammation (grade trace or above) in the study
eye at baseline, which is of clinical significance according to the investigator’s judgment, such
as active infections of the anterior segment; this includes conjunctivitis (except mild
blepharitis), keratitis, scleritis, idiopathic or autoimmune associated uveitis or endophthalmitis.
4) Any uncontrolled ocular hypertension or glaucoma in the study eye (defined as IOP greater than or equal to 26 mmHg,
despite treatment with anti-glaucomatous medication).
5) History of a medical, ocular or non-ocular condition, that in the judgment of the investigator,
would preclude a safe administration of the investigational product.
6) Visual Acuity Score (VAS) worse than 20 per 200 on Snellen’s chart, the generally accepted level
of legal blindness.
7) Topical ocular corticosteroids administered for at least 30 consecutive days within 3 months
before screening.
8) Current or planned use of systemic medications known to be toxic to the lens, retina or optic
nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines
and ethambutol.
9) Any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release
device implantation (approved or investigational) in the study eye at any time during the past 3
months.
10) Treatment with any IVT injection in the study eye within the 28 days prior to day 1.
11) Uncontrolled hypertension (defined as a systolic value ≥ 160 mmHg or diastolic value greater than or equal to 100
mmHg at Screening).
12) Documented medical history (i.e., within 6 months of screening) of thromboembolic events,
stroke, congestive heart failure, myocardial infarction, uncontrolled atrial fibrillation.
13) History of excessive bleeding, subconjunctival haemorrhages during the earlier IVT or taking medications can alter bleeding or coagulation.
14) Suspected or active ocular or periocular infection in either eye.
15) History of other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a condition that contraindicates the use
of ranibizumab or renders the patient at high risk for treatment complications in the
opinion of the investigator.
16) Participation in an investigational trial that involves treatment with any drug or device
(with the exception of vitamins and minerals) within 3 months prior to Day 1.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
To evaluate the ability of healthcare
providers (HCPs) to follow the Instructions
for use (IFU) to prepare and administer a 0.5
mg ranibizumab PFS intravitreal injection to
participants while maintaining aseptic
conditions in participants who are eligible to
receive treatment with ranibizumab
Percentage of Successful Task Completions
Percentage of PFS Usage Errors on Safety
Critical Tasks
Percentage of PFS Usage Errors on Essential
Tasks
Secondary Outcome
Outcome
TimePoints
To evaluate serious adverse events (SAEs)
and adverse events (AEs) that observed
within the seven-day study reporting period.
Occurrence of ocular AEs/SAEs in the study
eye during the study-reporting period
Target Sample Size
Total Sample Size="38" Sample Size from India="38" Final Enrollment numbers achieved (Total)= "38" Final Enrollment numbers achieved (India)="38"
Phase of Trial
Phase 3
Date of First Enrollment (India)
10/03/2025
Date of Study Completion (India)
07/11/2025
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="0" Months="1" 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
To evaluate the ability of healthcare providers (HCPs) to follow the Instructions for use (IFU) to prepare and administer a 0.5 mg ranibizumab PFS intravitreal injection to participants while maintaining aseptic conditions in participants who are eligible to receive treatment with ranibizumab