Health Condition 1: H32- Chorioretinal disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: Lupins Ranibizumab: 0.5 mg administered as monthly intravitreal injection for 3 months.
Control Intervention1: Lucentis: 0.5 mg administered as intravitreal injection.
Control Intervent
Sponsors
Ms Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Ambulatory men or women 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-Vascular endothelial growth factor [VEGF] naive) active@ choroidal neovascularization (CNV) lesions secondary to AMD. (If both eyes are affected and eligible, at Investigator’s discretion, only one eye should be selected as the study eye). 3. Best corrected visual acuity (BCVA) in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) testing, between 20/40 and 20/320 (Snellen equivalent), both inclusive before pupil dilation. 4. Willingness and ability to undertake all scheduled visits and assessments. 5. Women, who are of non-childbearing potential (surgically sterile or menopausal), OR, if of childbearing potential using effective birth control and non-pregnant & non-lactating for the duration of the study. @Active CNV is defined as presence of leakage or intra- or sub-retinal fluid demonstrated by optical coherence tomography (OCT) and confirmed by fluorescein angiography (FA)
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to ranibizumab or any of the components of study medication. 2. Known history of 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. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye as assessed by FA. 5. History of vitrectomy, submacular surgery, or other surgical intervention for AMD in the study eye. 6. Any other pathology involving the CNV lesion like retrofoveolar atrophy or permanent structural damage to fovea. 7. 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. 8. 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 intraocular pressure (IOP)-lowering treatment. 9. History of serious complications following surgery in the study eye within 1 year prior to randomization. 10. Previous treatment with intravenous anti-VEGF agents or intravitreal anti-VEGF agents such as Bevacizumab, Ranibizumab, Aflibercept, Pegaptanib, Brolucizumab in either of the eyes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Descriptive assessment of peak systemic drug levels (Cmax) after first doseTimepoint: Proportion of patients with anti-drug antibodies at day 28, 56, & 84. Incidence of treatment emergent adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Descriptive assessment of peak systemic drug levels (Cmax) after third dose. Descriptive assessment of trough systemic drug levels (Ctrough) before second & third dose.Timepoint: Proportion of patients with anti-drug antibodies at day 28, 56, & 84. Incidence of treatment emergent adverse events | — |
Countries
India
Contacts
Public ContactDr Neelam Kardekar
Lupin Limited
Outcome results
None listed