| CTRI Number |
CTRI/2026/01/100665 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical study to evaluate safety and efficacy of RaniEyes® (Lupin’s ranibizumab) in real world clinical practice. |
|
Scientific Title of Study
|
A prospective, multi-center, single arm, open label, phase 4 study to evaluate safety and efficacy of RaniEyes® (Lupin’s ranibizumab for intravitreal injection) in real world clinical practice. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LRP/LUBT010/2021/006 Version No.: 1.0, Dated: 25 Jan 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chirag Shah |
| Designation |
Director |
| Affiliation |
LUPIN LIMITED |
| Address |
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
Pune
MAHARASHTRA
412115
India |
| Phone |
02066749068 |
| Fax |
|
| Email |
chiragshah@lupin.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chirag Shah |
| Designation |
Director |
| Affiliation |
LUPIN LIMITED |
| Address |
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
Pune
MAHARASHTRA
412115
India |
| Phone |
02066749068 |
| Fax |
|
| Email |
chiragshah@lupin.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neelam Kardekar |
| Designation |
Assistant Director |
| Affiliation |
LUPIN LIMITED |
| Address |
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
Pune
MAHARASHTRA
412115
India |
| Phone |
02066747372 |
| Fax |
|
| Email |
neelamnkardekar@lupin.com |
|
|
Source of Monetary or Material Support
|
| Lupin Limited Biotechnology Division Gat No 1156 Village Ghotawade Taluka-Mulshi, Pune Pin 412115 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Lupin Limited |
| Address |
Lupin Research Park, Survey No 46A 47A Village Nande Tal Mulshi
Pune MAHARASHTRA 412115 India
Pune
MAHARASHTRA
412115
India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Lupin Limited |
Kalpataru Inspire, 3rd floor, Off western express highway, Santacruz (East), Mumbai (India) - 400055 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Ambade |
Ambade Eye Hospital |
1st Floor Kamla Tower Near Jaswant
Talkies Indora Square Kamptee Road Nagpur 440017
Nagpur
MAHARASHTRA |
9823178466
dr_ajayambade@rediffmail.com |
| Dr Himanshu Deshmukh |
Daulat Deshmukh Eye Hospital |
Ground floor room no 1 Khaperde Garden Amravati MS
444601 India
Amravati
MAHARASHTRA |
9823165687
deshmukheyeresearch@gamail.com |
| Dr Nilesh Giri |
Dr. DY Patil Medical College, Hospital & Research Centre |
Sant Tukaram Nagar Pimpri Pune 411018
Pune
MAHARASHTRA |
7776026323
nilesh.giri@dpu.edu.in |
| Dr Bibhuti P Kashyap |
Kashyap Memorial Eye Hospital Pvt. Ltd |
Kashyap Memorial Eye Hospital Complex Purulia Road
Purulia Rd near Dangratoli Chowk Ranchi (Jharkhand) 834001 India
Ranchi
JHARKHAND |
9811826765
drbibhutipkashyap@gmail.com |
| Dr Rohit Laul |
Modern Eye Hospital |
11/13 G Suyojit Modern Point Opp
Police Parade Ground Sharanpur Road Nashik 422002
Nashik
MAHARASHTRA |
9656442160
drlaulrs@gmail.com |
| Dr Shobhana Mange |
Shivam Retina Clinic and Eye Hospital |
HG-1A ITC Building Manjura Gate Ring Road Surat 395001
Surat
GUJARAT |
9898155070
drshobhanamange@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Dr. D. Y Patil Vidyapeeth, Pune, |
Approved |
| Kashyap Memorial Eye Hospital |
Approved |
| Unity Hospital Ethics Committee |
Submittted/Under Review |
| Veracity Independent Ethics Committee, Rock Arcad, Shop No. 55, Camp Road (Block) Tapowan Road Amravati Amravati Maharashtra |
Submittted/Under Review |
|
|
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 |
Not Applicable |
Not Applicable |
| Intervention |
RaniEyes® |
Lupins Ranibizumab administered as monthly intravitreal injection over a period of 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (men or women) with confirmed diagnosis of choroidal neovascularization (CNV) secondary to AMD or visual impairment due to DME
2. Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
3. Men and women of childbearing potential must be using adequate birth control measures |
|
| ExclusionCriteria |
| Details |
1. Choroidal neovascularization or visual impairment in the study eye due to causes other than AMD or DME
2. Patients receiving other anti-VEGF therapies
3. Uncontrolled glaucoma
4. Patients with uncontrolled diabetes mellitus
5. Intraocular surgery (including cataract surgery) within 2 months in the study eye
6. Active intraocular inflammation or ongoing infection in the study eye.
7. Patients with active proliferative diabetic retinopathy.
8. Patients with vitreous hemorrhage.
9. Active or ongoing ocular infection or severe inflammation in either of the eyes.
10. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that contraindicates the use of ranibizumab. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of treatment emergent adverse events |
Over period of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients with improved/maintained visual acuity at the end of study. |
Over a period of 6 months |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
20/01/2026 |
| 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="6"
Days="0" |
|
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
Modification(s)
|
RaniEyes® (Lupin’s ranibizumab) is an approved ranibizumab biosimilar in India. This Phase 4 clinical study is being conducted in patients with neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) to further evaluate the safety, efficacy, and immunogenicity of RaniEyes® in real world clinical practice. Patients with neovascular AMD or DME who provide written informed consent will be screened for this study. Eligible patients will be treated with RaniEyes® 0.5 mg (0.05 mL of 10 mg/mL ranibizumab) intravitreal injection over a period of 6 months. Safety, efficacy, and immunogenicity assessment will be done periodically during the course of the study. |