NCT05834075

A Retrospective Study to Evaluate the Early Real-world Evidence of Brolucizumab in Patients With Neovascular Age-related Macular Degeneration (nAMD) in India

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 63 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This non-interventional, retrospective, observational, noncomparative, non-randomized, single-arm, multi-centre study included patients (≥50 years) diagnosed with neovascular age-related macular degeneration (nAMD) in at least 1 eye. Anonymized data of patients treated with brolucizumab intravitreal injection (IVI) who had received the first dose of brolucizumab between 01 October 2020 and 31 March 2021 was collected. Patients could either be treatment-naïve or previously treated with single or a combination of other IVI of anti-vascular endothelial growth factors (VEGFs). The primary outcome measure was the change in fluid levels (intra-retinal fluid \[IRF\], sub-retinal fluid \[SRF\], and pigment epithelial detachment \[PED\]) from baseline to Month 3. Secondary outcome measures included change in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), number of brolucizumab injections, and safety (number of adverse events \[AEs\]). Descriptive statistics were tabulated for the demographic and clinical characteristics as well as outcome variables.

Conditions

• Neurovascular Age-related Macular Degeneration

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-04-22
• Completion: 2022-04-22
• First posted: 2023-04-28
• Last updated: 2023-04-28

Locations

4 sites across 1 country: India