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Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial.

Publication ,  Journal Article
Dugel, PU; Jaffe, GJ; Sallstig, P; Warburton, J; Weichselberger, A; Wieland, M; Singerman, L
Published in: Ophthalmology
September 2017

PURPOSE: To compare the efficacy and safety of brolucizumab with aflibercept to treat neovascular age-related macular degeneration (AMD). DESIGN: Prospective, randomized, double-masked, multicenter, 2-arm, phase 2 study. PARTICIPANTS: Eighty-nine treatment-naïve participants, aged ≥50 years, with active choroidal neovascularization secondary to AMD. METHODS: Eligible participants were randomized 1:1 to intravitreal brolucizumab (6 mg/50 μl) or aflibercept (2 mg/50 μl). Both groups received 3 monthly loading doses and were then treated every 8 weeks (q8) with assessment up to week 40. In the brolucizumab group, the final q8 cycle was extended to enable 2 cycles of treatment every 12 weeks (q12; to week 56); participants on aflibercept continued on q8. Unscheduled treatments were allowed at the investigator's discretion. MAIN OUTCOME MEASURES: The primary and secondary hypotheses were noninferiority (margin: 5 letters at a 1-sided alpha level 0.1) in best-corrected visual acuity (BCVA) change from baseline of brolucizumab versus aflibercept at weeks 12 and 16, respectively. BCVA, central subfield thickness (CSFT), and morphologic features were assessed throughout the study. RESULTS: The mean BCVA change from baseline (letters) with brolucizumab was noninferior to aflibercept at week 12 (5.75 and 6.89, respectively [80% confidence interval for treatment difference, -4.19 to 1.93]) and week 16 (6.04 and 6.62 [-3.72 to 2.56]), with no notable differences up to week 40. Outcomes exploring disease activity during the q8 treatment cycles suggest greater stability of the brolucizumab participants, supported by receipt of fewer unscheduled treatments versus aflibercept (6 vs. 15) and more stable CSFT reductions. In addition, from post hoc analysis, a greater proportion of brolucizumab-treated eyes had resolved intraretinal and subretinal fluid compared with aflibercept-treated eyes. Approximately 50% of brolucizumab-treated eyes had stable BCVA during the q12 cycles. Brolucizumab and aflibercept adverse events were comparable. CONCLUSIONS: During the matched q8 phase, the BCVA in brolucizumab-treated eyes appeared comparable to aflibercept-treated eyes, with more stable CSFT reductions, receipt of fewer unscheduled treatments, and higher rates of fluid resolution. The brolucizumab safety profile was similar to aflibercept over 56 weeks of treatment. A 12-week treatment cycle for brolucizumab may be viable in a relevant proportion of eyes.

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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

September 2017

Volume

124

Issue

9

Start / End Page

1296 / 1304

Location

United States

Related Subject Headings

  • Wet Macular Degeneration
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Tomography, Optical Coherence
  • Retina
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Prospective Studies
  • Ophthalmology & Optometry
  • Middle Aged
 

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Dugel, P. U., Jaffe, G. J., Sallstig, P., Warburton, J., Weichselberger, A., Wieland, M., & Singerman, L. (2017). Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology, 124(9), 1296–1304. https://doi.org/10.1016/j.ophtha.2017.03.057
Dugel, Pravin U., Glenn J. Jaffe, Peter Sallstig, James Warburton, Andreas Weichselberger, Mark Wieland, and Lawrence Singerman. “Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial.Ophthalmology 124, no. 9 (September 2017): 1296–1304. https://doi.org/10.1016/j.ophtha.2017.03.057.
Dugel PU, Jaffe GJ, Sallstig P, Warburton J, Weichselberger A, Wieland M, et al. Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology. 2017 Sep;124(9):1296–304.
Dugel, Pravin U., et al. “Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial.Ophthalmology, vol. 124, no. 9, Sept. 2017, pp. 1296–304. Pubmed, doi:10.1016/j.ophtha.2017.03.057.
Dugel PU, Jaffe GJ, Sallstig P, Warburton J, Weichselberger A, Wieland M, Singerman L. Brolucizumab Versus Aflibercept in Participants with Neovascular Age-Related Macular Degeneration: A Randomized Trial. Ophthalmology. 2017 Sep;124(9):1296–1304.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

September 2017

Volume

124

Issue

9

Start / End Page

1296 / 1304

Location

United States

Related Subject Headings

  • Wet Macular Degeneration
  • Visual Acuity
  • Vascular Endothelial Growth Factor A
  • Tomography, Optical Coherence
  • Retina
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Prospective Studies
  • Ophthalmology & Optometry
  • Middle Aged