Health Condition 1: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
Intervention1: Brolucizumab Injection (120mg/ml): A real-world, prospective, multi-center, open-label, phase IV clinical study to evaluate the safety and effectiveness of intravitreal injections (IVI)
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Female or male, treatment naïve patient with =50 years of age, with neovascular age-related macular degeneration (nAMD). Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study. Note: In case where both eyes are affected, data of only one eye [‘study eye’] will be recorded. selection of the eye to be considered for the purpose of the study [referred to as ‘study eye’] will be as per the Investigator’s discretion.
Exclusion criteria
Exclusion criteria: Patient having other eye diseases that could compromise the visual acuity (VA). Patient with existing or suspected ocular or periocular infection in the study eye. Patient with an existing intraocular inflammation (IOI). Patient with uncontrolled glaucoma defined as intraocular pressure > 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator’s judgment. Patient who has undergone intraocular surgery within 3 months prior to enrollment in this study. Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and characteristics of treatment-emergent adverse eventsTimepoint: baseline to Week 56. | — |
Secondary
| Measure | Time frame |
|---|---|
| Characterize the number of anti-VEGF injections, number of non-injection visits, and total number of visitsTimepoint: baseline to Week 56.;Estimate effect of brolucizumab on central subfield thickness (CST)Timepoint: baseline to week 16 and week 56.;Estimate effect of brolucizumab on fluidTimepoint: baseline to week 16 and week 56.;Estimate the percentage (%) of patient eyes with anti-VEGF injection intervals q8w and q12wTimepoint: baseline to Week 56.;To evaluate the effectiveness of brolucizumab in the management of nAMD in terms of change in best-corrected visual acuity (BCVA)Timepoint: baseline to Week 56. | — |
Countries
India
Contacts
Public ContactDr. Anup Thorat
Novartis Healthcare Private Limited
Outcome results
None listed