To evaluate the safety and effectiveness of intravitreal injections of brolucizumab in patients with neovascular age-related macular degeneratio
- Conditions
- Health Condition 1: H578- Other specified disorders of eye and adnexa
- Registration Number
- CTRI/2022/01/039718
- Lead Sponsor
- ovartis Healthcare Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 105
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence and characteristics of treatment-emergent adverse eventsTimepoint: baseline to Week 56.
- Secondary Outcome Measures
Name Time Method 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.