Status:
COMPLETED
Study to Evaluate the Safety and Effectiveness of Intravitreal Injections (IVI) of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Neovascular Age-related Macular Degeneration (nAMD)
Eligibility:
All Genders
50-100 years
Phase:
PHASE4
Brief Summary
The purpose of this study was to generate additional safety and effectiveness data in Indian neovascular age-related macular degeneration (nAMD) patients that more closely resemble the real-world popu...
Detailed Description
The study was a prospective, multi-center, open-label, interventional phase IV clinical study. The study treatment, i.e., brolucizumab was prescribed in terms of the marketing authorization; the assi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT05269966
Start Date
March 9 2022
End Date
August 29 2023
Last Update
March 20 2025
Active Locations (10)
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1
Novartis Investigative Site
Asarwa, Ahmedabad, India, 380016
2
Novartis Investigative Site
Ahmedabad, Gujarat, India, 380052
3
Novartis Investigative Site
Bangalore, Karnataka, India, 560 010
4
Novartis Investigative Site
Chennai, Tamil Nadu, India, 600018