Results from the 48-week PULSAR trial show that intravitreal aflibercept 8 mg is effective in treating neovascular age-related macular degeneration, supporting its use as a treatment option.
In the recent Lancet publication titled "Intravitreal aflibercept 8 mg in neovascular age-related macular degeneration (PULSAR): 48-week results from a randomised, double-masked, non-inferiority, phase 3 trial", the authors delve into a comprehensive study evaluating the efficacy and safety of intravitreal aflibercept 8 mg compared to aflibercept 2 mg in patients with neovascular age-related macular degeneration (nAMD). This phase 3 trial, known as PULSAR, involved a large number of participants across 223 sites worldwide and aimed to investigate the potential benefits of aflibercept 8 mg in terms of extended dosing intervals and sustained disease control in nAMD patients.
The study design included a randomised, double-masked, active-controlled approach with three parallel treatment groups: aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), and aflibercept 8 mg every 16 weeks (8q16). Key assessments included best-corrected visual acuity (BCVA), intraocular pressure, indirect ophthalmoscopy, and spectral-domain optical coherence tomography (SD-OCT) at scheduled visits. Patients receiving aflibercept 8 mg had their dosing intervals adjusted based on pre-specified dose regimen modification criteria indicating disease activity. The primary endpoint was the change in BCVA at week 48, with additional secondary efficacy measures such as the proportion of patients with no fluid in the centre subfield and changes in central retinal thickness (CRT) and choroidal neovascularisation size.
Findings from the study indicated that aflibercept 8 mg at 12-week and 16-week intervals demonstrated non-inferior BCVA gains compared to aflibercept 2 mg, with no significant differences in ocular adverse events among the treatment groups. The aflibercept 8 mg groups also showed superiority in maintaining a dry macula at week 16 and up to week 48. Additionally, a significant proportion of patients in the aflibercept 8 mg groups were able to maintain their assigned dosing regimens, showcasing the potential for extended treatment intervals with aflibercept 8 mg.
The safety profile of aflibercept 8 mg was comparable to that of aflibercept 2 mg, with no new safety concerns identified. Ocular and non-ocular treatment-emergent adverse events were similar across the treatment groups, and the incidences of hypertension events and deaths were low and consistent among the groups. The study also provided insights into the management of nAMD, highlighting the potential of aflibercept 8 mg to reduce treatment burden while offering improved anatomic outcomes and similar visual gains compared to aflibercept 2 mg.
In conclusion, the PULSAR trial findings support the efficacy and safety of aflibercept 8 mg with extended dosing intervals in patients with nAMD. The study contributes valuable data to the field of ophthalmology, suggesting that aflibercept 8 mg could be a promising treatment option for achieving sustained disease control and potentially optimizing the management of nAMD patients in clinical practice.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00063-1/fulltext
The study design included a randomised, double-masked, active-controlled approach with three parallel treatment groups: aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), and aflibercept 8 mg every 16 weeks (8q16). Key assessments included best-corrected visual acuity (BCVA), intraocular pressure, indirect ophthalmoscopy, and spectral-domain optical coherence tomography (SD-OCT) at scheduled visits. Patients receiving aflibercept 8 mg had their dosing intervals adjusted based on pre-specified dose regimen modification criteria indicating disease activity. The primary endpoint was the change in BCVA at week 48, with additional secondary efficacy measures such as the proportion of patients with no fluid in the centre subfield and changes in central retinal thickness (CRT) and choroidal neovascularisation size.
Findings from the study indicated that aflibercept 8 mg at 12-week and 16-week intervals demonstrated non-inferior BCVA gains compared to aflibercept 2 mg, with no significant differences in ocular adverse events among the treatment groups. The aflibercept 8 mg groups also showed superiority in maintaining a dry macula at week 16 and up to week 48. Additionally, a significant proportion of patients in the aflibercept 8 mg groups were able to maintain their assigned dosing regimens, showcasing the potential for extended treatment intervals with aflibercept 8 mg.
The safety profile of aflibercept 8 mg was comparable to that of aflibercept 2 mg, with no new safety concerns identified. Ocular and non-ocular treatment-emergent adverse events were similar across the treatment groups, and the incidences of hypertension events and deaths were low and consistent among the groups. The study also provided insights into the management of nAMD, highlighting the potential of aflibercept 8 mg to reduce treatment burden while offering improved anatomic outcomes and similar visual gains compared to aflibercept 2 mg.
In conclusion, the PULSAR trial findings support the efficacy and safety of aflibercept 8 mg with extended dosing intervals in patients with nAMD. The study contributes valuable data to the field of ophthalmology, suggesting that aflibercept 8 mg could be a promising treatment option for achieving sustained disease control and potentially optimizing the management of nAMD patients in clinical practice.
Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00063-1/fulltext
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