Health Condition 1: H353- Degeneration of macula and posterior pole
Conditions
Interventions
Intervention1: RaniEyes : Lupins Ranibizumab administered as monthly intravitreal injection over a period of 6 months.
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Lupin Limited
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (men or women) with confirmed diagnosis of choroidal neovascularization (CNV) secondary to AMD or visual impairment due to DME 2. Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements. 3. Men and women of childbearing potential must be using adequate birth control measures
Exclusion criteria
Exclusion criteria: 1. Choroidal neovascularization or visual impairment in the study eye due to causes other than AMD or DME 2. Patients receiving other anti-VEGF therapies 3. Uncontrolled glaucoma 4. Patients with uncontrolled diabetes mellitus 5. Intraocular surgery (including cataract surgery) within 2 months in the study eye 6. Active intraocular inflammation or ongoing infection in the study eye. 7. Patients with active proliferative diabetic retinopathy. 8. Patients with vitreous hemorrhage. 9. Active or ongoing ocular infection or severe inflammation in either of the eyes. 10. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that contraindicates the use of ranibizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment emergent adverse eventsTimepoint: Over period of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with improved/maintained visual acuity at the end of study.Timepoint: Over a period of 6 months | — |
Countries
India
Contacts
Public ContactDr Neelam Kardekar
LUPIN LIMITED
Outcome results
None listed