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.
Study Type
OBSERVATIONAL
Enrollment
63
Narayana Nethralaya
Bangalore, India
Disha Eye Hospital
Kolkata, India
Susrut Eye Foundation and Research Center
Kolkata, India
Dr. Milan's Retina Care Center
Rajkot, India
Percentage of patients with absence or reduction of IRF at Month 3 compared to baseline
Percentage of patients with either absence of intra-retinal fluid (IRF) at Month 3 or a reduction of IRF at Month 3 compared to baseline.
Time frame: From baseline to Month 3
Percentage of patients with absence or reduction of SRF at Month 3 compared to baseline
Percentage of patients with either absence of sub-retinal fluid (SRF) at Month 3 or a reduction of SRF at Month 3 compared to baseline.
Time frame: From baseline to Month 3
Percentage of patients with absence or reduction of PED at Month 3 compared to baseline
Percentage of patients with either absence of pigment epithelial detachment (PED) at Month 3 or a reduction of PED at Month 3 compared to baseline.
Time frame: From baseline to Month 3
Mean change from baseline in BCVA at Month 3 as measured by logarithm of the minimum angle of resolution (logMAR)
Time frame: Baseline and Month 3
Percentage of patients with absence or reduction of IRF at Months 1 and 2 compared to baseline
Time frame: Baseline, Months 1 and 2
Percentage of patients with absence or reduction of SRF at Months 1 and 2 compared to baseline
Time frame: Baseline, Months 1 and 2
Percentage of patients with absence or reduction of PED at Months 1 and 2 compared to baseline
Time frame: Baseline, Months 1 and 2
Mean change from baseline in CRT at Months 1, 2, and 3 as assessed by optical coherence tomography (OCT)
Time frame: Baseline, Months 1, 2, and 3
Number of brolucizumab injections during Months 1, 2, and 3 of brolucizumab treatment
Time frame: Months 1, 2, and 3
Number of non-injection visits during Months 1, 2, and 3 of brolucizumab treatment
Time frame: Months 1, 2, and 3
Number of visits during Months 1, 2, and 3 of brolucizumab treatment
Time frame: Months 1, 2, and 3
Number of patients with treatment-emergent adverse events
Time frame: Baseline to Month 3
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