Clinical trial to compare effects and safety of Lupins Ranibizumab with Lucentis® in Patients with Age-Related loss of central vision.
Phase 3
Active, not recruiting
- Conditions
- Degeneration of macula and posterior pole,
- Registration Number
- CTRI/2019/03/018322
- Lead Sponsor
- Lupin Limited Biotechnology Division
- Brief Summary
This is a randomized, comparative, parallel group, two arm, double blind, multi-center Phase 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. Theresults of this study showed that Lupin’s ranibizumab demonstrates therapeuticequivalence to Lucentis in terms of changes in best corrected visual acuity(BCVA) measured in terms of proportion of patients losing fewer than 15 lettersfrom baseline as well as mean change in BCVA from baseline in patients withneovascular age-related macular degeneration. Furthermore, Lupin’s Ranibizumabdemonstrated comparable safety and immunogenicity profile. Lupin’s Ranibizumabhas received marketing authorization on 02 November 2021 by CDSCO
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method Efficacy: Mean change in Best Corrected Visual Acuity (BCVA) from baseline in the study eye at the end of 3 months. Safety: Adverse Events (AE) assessment Immunogenicity: Proportion of patients with anti-drug antibodies.
Trial Locations
- Locations (32)
B B Eye Foundation
🇮🇳Kolkata, WEST BENGAL, India
B J Government Medical College and Sassoon General Hospital
🇮🇳Pune, MAHARASHTRA, India
Bankers Retina Clinic & Laser Centre
🇮🇳Ahmadabad, GUJARAT, India
D Y Patil Medical College & Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Deoyani hospital
🇮🇳Pune, MAHARASHTRA, India
Dhadiwal Hospital
🇮🇳Nashik, MAHARASHTRA, India
Dr B R Ambedkar Medical College and Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr. Virendra Laser, Phaco Surgery Center
🇮🇳Jaipur, RAJASTHAN, India
GMERS Medical College and Civil Hospital
🇮🇳Ahmadabad, GUJARAT, India
Gurushree Hi-Tech Multispeciality Hospital
🇮🇳Bangalore, KARNATAKA, India
Scroll for more (22 remaining)B B Eye Foundation🇮🇳Kolkata, WEST BENGAL, IndiaDr Saurav SinhaPrincipal investigator9831808203drssinharesearch@gmail.com