CTRI/2019/03/018322 [Registered on: 29/03/2019] Trial Registered Prospectively
Last Modified On:
09/03/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Clinical trial to compare effects and safety of Lupins Ranibizumab with Lucentis® in Patients with Age-Related loss of central vision.
Scientific Title of Study
A Prospective, Randomized, Parallel Group, Double Blind, Multicenter Study to Compare the Efficacy, Safety & Immunogenicity of Lupin’s Ranibizumab with Lucentis® in Patients with Neovascular Age-Related Macular Degeneration
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
LRP/RBZ/2015/002 V1.1 02 Aug 2018
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Chirag Shah
Designation
Associate Director
Affiliation
Lupin Limited
Address
1st Floor, A Wing Green Bldg, NDDD Dept. Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune MAHARASHTRA 412115 India
Pune MAHARASHTRA 412115 India
Phone
020-66749068
Fax
Email
chiragshah@lupin.com
Details of Contact Person Scientific Query
Name
Dr Dhananjay Bakhle
Designation
Executive Vice President
Affiliation
Lupin Limited
Address
LRP, Old Building, 2nd Floor, Dept. NDDD, Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune MAHARASHTRA 412115 India
Pune MAHARASHTRA 412115 India
Phone
020-66749054
Fax
Email
dhananjaybakhle@lupin.com
Details of Contact Person Public Query
Name
Dr Dhananjay Bakhle
Designation
Executive Vice President
Affiliation
Lupin Limited
Address
LRP, Old Building, 2nd Floor, Dept. NDDD, Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune MAHARASHTRA 412115 India
B J Government Medical College and Sassoon General Hospital
OPD 69 Department of Ophthalmology B J Government Medical College and Sassoon General Hospital Jaiprakash Narayan Road Near Pune Railway Station Pune MAHARASHTRA
The Ethics Committee of the Eye Foundation, Coimbatore
Approved
The Institutional Ethics Committee B J Medical College and Civil Hospital Ahmedabad
Approved
Yash Societys Sujata Birla Hospital Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
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
Lucentis®
Lucentis® supplied as single-use, 2-cc glass vial containing 2.3 mg of ranibizumab in 0.23 mL solution designed to deliver 0.05 mL of 10 mg/mL ranibizumab. Dose of 0.5 mg.Intravitreal injection in the study eye of patients Total three injections per patient; Once monthly. The total study duration is 3.5 months (screening period of 14 days and treatment duration is of 3 months).
Intervention
Lupin’s Ranibizumab
Lupin’s Ranibizumab supplied as single-use, 2-cc glass vial containing 2.3 mg of ranibizumab in 0.23 mL solution designed to deliver 0.05 mL of 10 mg/mL ranibizumab. Dose of 0.5 mg. Intravitreal injection in the study eye of patients. Total three injections per patient; Once monthly. The total study duration is 3.5 months (screening period of 14 days and treatment duration is of 3 months).
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Ambulatory male or female participants with age ≥ 50 years at the time of screening who are capable of understanding and giving written informed consent.
2.Primary or recurrent active choroidal neovascularization (CNV) lesions involving the foveal centre secondary to age-related macular degeneration in any one of the eye. (If both eyes are affected and eligible patient and study ophthalmologist will select one eye for study purpose).
3.Best corrected visual acuity in the study eye using ETDRS testing between 20/ 40 and 20/ 320 (Snellen equivalent) both inclusive before pupil dilation.
4.Females who are of non-child bearing potential (surgically sterile or menopausal) OR if of child bearing potential using effective birth control and non-pregnant & non-lactating.
ExclusionCriteria
Details
Patients who meet any of the following criteria should be disqualified from entering the study:
1. Known hypersensitivity to ranibizumab or any of the components of study medication.
2. Allergy to fluorescein dye.
3. Patients with coexisting CNV lesions secondary to AMD in the non-study eye that would require simultaneous treatment with anti-VEGF therapies during the study period.
Ocular Conditions of the study eye:
4. Any other pathology involving the CNV lesion like retrofoveolar atrophy or permanent structural damage to fovea or fibrosis/ hemorrhage involving fovea > 50 % of lesion area of study eye that can affect the efficacy of drug.
5. Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tear involving the macula or macular hole (stage 3 or 4) in the study eye.
6. Aphakia or absence of the posterior capsule in the study eye.
7. Uncontrolled glaucoma as evident by progressive damage to optic nerve or visual fields despite optimum therapy; or steroid-induced glaucoma with continued use of steroids that requires IOP-lowering treatment.
8. H/o serious complications following surgery in the study eye within 1 year prior to randomization.
Concomitant Medications/ Treatments & Procedures:
9. Previous treatment with intravenous Bevacizumab (Avastin®), or intravitreal Ranibizumab (Lucentis®), Bevacizumab (Avastin®), Aflibercept (Eylea®), Pegaptanib (Macugen®) in either of the eyes.
10. Previous external beam radiation or subfoveal focal laser photocoagulation/ thermal laser or transpupillary thermotherapy in the study eye within 5 years prior to randomization.
11. Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy, intravitreal or protein kinase C inhibitors or other AMD therapy in the study eye within 3 months prior to randomization.
12. Previous treatment with intravitreal ocular or periocular steroids (e.g., triamcinolone, anecortave acetate) or intravitreal or peribulbar steroid in the study eye within past 3 months.
13. Concurrent use of systemic anti-VEGF agents.
14. History of vitrectomy, submacular surgery or other surgical intervention for AMD, corneal transplant or any device implantation in the study eye.
15. Intraocular surgery (including cataract surgery) in the study eye within 2 months prior to randomization.
16. Concurrent treatment with an investigational drug or device in the non-study eye.
17. Previous participation in any studies of investigational drugs within 30 days or as prescribed in that study (whichever is later) preceding the initial study treatment.
Other Ocular Conditions:
18. CNV in the study eye due to causes other than AMD such as histoplasmosis, trauma, or pathological myopia etc. or CNV lesion not likely to respond to ranibizumab.
19. Active or ongoing ocular infection (e.g. infectious conjunctivitis, keratitis, scleritis, or endophthalmitis) or severe inflammation in either of the eyes.
20. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 month study period or that could contribute to a loss (of at least 2 Snellen equivalent lines) of best corrected visual acuity over the 3 months study period (e.g. diabetic retinopathy, progressive retinal disease or retinal pathology, cataract, glaucoma, uveitis, previous corneal transplant, the refractive error more than -8 diopters of myopia etc.). The decision regarding exclusion is to be based on the opinion of the investigator.
General Conditions:
21. Patients with seropositivity for hepatitis B, hepatitis C, HIV antibody, syphilis tests or any immunodeficiency and/ or immunosuppressive disease or active systemic infection.
22. History or presence of concurrent systemic diseases or dysfunctions requiring significant medical/ surgical intervention during study period that might affect interpretation of the results or contraindicates the use of ranibizumab or render the subject at high risk for treatment complications based on the Investigator’s judgment such as:
• Cardiovascular disease (e.g. stroke, myocardial infarction), uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic (e.g. optic neuropathy), metabolic, pulmonary, autoimmune disease or psychiatric disease based on previous history and relevant reports of clinical examination, laboratory tests, or ECG etc.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant and Investigator Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients losing fewer than 15 letters (approximately 3 lines) from baseline Best Corrected Visual Acuity (BCVA) in the study eye at the end of 3 months, assessed with the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
At the end of 3 months
Secondary Outcome
Outcome
TimePoints
Efficacy:
Mean change in Best Corrected Visual Acuity (BCVA) from baseline in the study eye at the end of 3 months.
Immunogenicity:
Proportion of patients with anti-drug antibodies.
Day 1 Day 31 Day 90
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"
This is a randomized, comparative, parallel group, two arm, double blind, multi-centerPhase 3 clinical study. The objective of the study is to compare the efficacy, safety and immunogenicity of Lupin’s Ranibizumab to that of Lucentis® in patients with neovascular age-related macular degeneration.
Results:
This study has been completed. The
results of this study showed that Lupin’s ranibizumab demonstrates therapeutic
equivalence to Lucentis in terms of changes in best corrected visual acuity
(BCVA) measured in terms of proportion of patients losing fewer than 15 letters
from baseline as well as mean change in BCVA from baseline in patients with
neovascular age-related macular degeneration. Furthermore, Lupin’s Ranibizumab
demonstrated comparable safety and immunogenicity profile. Lupin’s Ranibizumab
has received marketing authorization on 02 November 2021 by CDSCO