Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: Lupins Ranibizumab: 0.5 mg once monthly as intravitreal injection for 12 months. The total study
duration is approximately 13 months (screening period of 28 days and treatment duration
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 (anti-VEGF naïve) active@ CNV lesions involving the foveal center secondary to AMD in any one of the eye. (If both eyes are affected and eligible, ophthalmologist should consider the worst eye in preference to the other, if the other eye can await treatment with anti-VEGF for one year). 3. BCVA in the study eye, using ETDRS testing, between 20/ 40 and 20/ 200 (Snellen equivalent), both inclusive before pupil dilation. 4. Willingness and ability to undertake all scheduled visits and assessments. 5. 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 during the study and 3 months after the last dose (Refer Section2 - Definition of Terms). @ Active CNV is defined as any leakage detected on FA or OCT
Exclusion criteria
Exclusion criteria: 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. 4. Patients with very advanced AMD (upper limit 20/40) and very low baseline visual acuity (lowest baseline 20/200). 5. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA (confirmed by independent central reading center). 6. Subretinal hemorrhage in the study eye that involves the center of the fovea, the size of the hemorrhage is either = 50% of the total lesion area or = 1 disc area in size (confirmed by independent central reading center). 7. Total lesion area = 12.0 disc areas (DA) in size (including blood, scars, and neovascularization) as assessed by FA in the study eye (confirmed by independent central reading center). 8. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye. 9. Employees of clinical study sites, individuals directly involved with the conduct of the study or immediate family members thereof, prisoners, and persons who are legally institutionalized. 10. 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. 11. Vitreous hemorrhage or history of rhegmatogenous retinal detachment, retinal pigment epithelial tears or rips involving the macula or macular hole (stage 1 to 4) in the study eye as assessed by FA (confirmed by independent central reading center). 12. 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. 13. History of serious complications following surgery in the study eye within 1 year prior to randomization. 14. Previous treatment with intravenous Bevacizumab (Avastin®), or intravitreal Ranibizumab (Lucentis®), Bevacizumab (Avastin®), Aflibercept (Eylea®), Pegaptanib (Macugen®) in either of the eyes. 15. Previous external beam radiation or any laser therapy photocoagulation/ thermal laser thermotherapy/ verteporfin photodynamic therapy (PDT) involving the foveal center in the study eye within 5 years prior to randomization. 16. Previous treatment with verteporfin photodynamic therapy (PDT), thermal laser, transpupillary thermotherapy (except subfoveal) in the study eye or use of protein kinase C inhibitors within 3 months prior to randomization. 17. Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization. 18. Previous treatment with intravitreal steroid implant (like Ozurdex®) within 6 months prior to randomization. 19. Concurrent use of systemic anti-VEGF agents. 20. Intraocular surgery (including cataract surgery) in the study eye within 3 months prior to randomization. 21. Concurrent treatment with an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in BCVA from baseline in the study eye at the end of 12 months, assessed with the ETDRS chartTimepoint: at the end of 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: Mean change in BCVA from baseline in the study eye at the end of 3 months, assessed with ETDRS chart Mean change in BCVA from baseline in the study eye at the end of 6 and 9 months assessed with ETDRS chartTimepoint: at the end of 3 months at the end of 6 and 9 months;Safety Adverse Event ( AE) assessment, ocular and non-ocular Ophthalmic examination Physical and systemic examination Vital Signs Electrocardiogram (ECG) Laboratory parameters: Blood (hematology & biochemistry) and urinalysis Timepoint: Screening visit to end of study visit;Immunogenicity: Proportion of patients with anti-drug antibodies at the end of 1,3,6,9 and 12 monthsTimepoint: at the end of 1, 3, 6, 9, and 12 months | — |
Countries
Bulgaria, Czech Republic, Estonia, Hungary, India, Latvia, Poland, Slovakia, United States of America
Contacts
Public ContactDr Neelakant Krishnan
Lupin Limited
Outcome results
None listed