Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Neovascular Age-related Macular Degeneration (nAMD)
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD) focused on measuring Macular degeneration, age-related macular degeneration (ARMD), vision loss, macula damage, retina damage, dry macular degeneration, wet macular degeneration, Subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration
Eligibility 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:
- Patients fulfilling any of the following criteria are not eligible for this study:
- Patient having other eye diseases that could compromise the 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.
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Experimental
Brolucizumab
Brolucizumab, formerly known as ESBA1008, is a humanized single-chain Fv (scFv) antibody fragment. Its Intravitreal injections. Brolucizumab 6 mg will be administered by IVT injection as per the Prescribing information (PI) and in line with the treating physician's clinical judgement. Patients will receive loading doses of brolucizumab at Day 0/Visit 1, Week 4/Visit 2 and Week 8/Visit 3. After the loading doses, at Week 16, disease activity assessment (DAA) will be performed based on BCVA and OCT to assess whether the patient will require q8w or q12w dosing.