Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: 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/
Once monthly. The total study duration is 3.5 months (screening period of 14 days and treatment duration is of 3 months).
Control Intervention1: Lucentis�®: Lucentis�® supplied as single-use, 2-cc
Once monthly. The total study duration is 3.5 months (screening period of 14 days and treatment duration is of 3 months).
Sponsors
Lupin Limited Biotechnology Division
Eligibility
Inclusion criteria
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
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. 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 ove
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: At the end of 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Mean change in Best Corrected Visual Acuity (BCVA) from baseline in the study eye at the end of 3 months. Timepoint: At the end of 3 months;Immunogenicity: Proportion of patients with anti-drug antibodies. Timepoint: Day 1 Day 31 Day 90;Safety: Adverse Events (AE) assessment Ophthalmic examination Physical & systemic examination Vital signs ECGs Laboratory parameters: Blood (hematology & biochemistry) and urinalysis Systemic VEGF inhibition Timepoint: Screening visit to end of study visit | — |
Countries
India
Contacts
Public ContactDr Dhananjay Bakhle
Lupin Limited
Outcome results
None listed