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MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid.

Publication ,  Journal Article
Khanani, AM; Brown, DM; Jaffe, GJ; Wykoff, CC; Adiguzel, E; Wong, R; Meng, X; Heier, JS; MERLIN Investigators,
Published in: Ophthalmology
September 2022

PURPOSE: To assess the 52-week efficacy and safety of brolucizumab 6 mg administered every 4 weeks compared with aflibercept 2 mg dosed every 4 weeks in eyes with neovascular age-related macular degeneration (nAMD) and persistent retinal fluid. DESIGN: Multicenter, randomized, double-masked phase 3a study. PARTICIPANTS: Participants with recalcitrant nAMD (persistent residual retinal fluid despite previous frequent anti-vascular endothelial growth factor treatment). METHODS: Eyes were randomized (2:1) to intravitreal brolucizumab 6 mg or aflibercept 2 mg every 4 weeks up to and including week 100. MAIN OUTCOME MEASURES: The primary end point was analysis of noninferiority in mean best-corrected visual acuity (BCVA) change from baseline to week 52 (margin, 4 letters). Other key end points included change in central subfield thickness (CST) from baseline to week 52, fluid-free status (no intraretinal fluid and no subretinal fluid), and safety. RESULTS: At week 52, brolucizumab was noninferior to aflibercept in BCVA change from baseline (least squares mean difference, -0.6 Early Treatment Diabetic Retinopathy Study letters; 95% confidence interval [CI], -2.1 to 0.9; P < 0.001). A total of 4.8% and 1.7% of participants reported a 15-letter or more BCVA loss from baseline at week 52 in the brolucizumab and aflibercept groups, respectively. In eyes treated with brolucizumab compared with those treated with aflibercept, the CST was reduced significantly (P < 0.001), and a significantly greater proportion of eyes were fluid free at week 52 (40.4% brolucizumab vs. 19.0% aflibercept; 95% CI, 13.9-29.0; P < 0.001). Incidence of intraocular inflammation (IOI), including retinal vasculitis and retinal vascular occlusion, were 9.3% (0.8% and 2.0%) for brolucizumab versus 4.5% (0% and 0%) for aflibercept, respectively. CONCLUSIONS: Visual acuity outcomes in previously treated participants with nAMD and persistent retinal fluid receiving brolucizumab 6 mg dosed every 4 weeks were noninferior to aflibercept 2 mg dosed every 4 weeks, with superior anatomic outcomes. However, incidences of IOI, including retinal vasculitis and retinal vascular occlusion, also were higher, leading to study termination.

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Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

September 2022

Volume

129

Issue

9

Start / End Page

974 / 985

Location

United States

Related Subject Headings

  • Wet Macular Degeneration
  • Treatment Outcome
  • Retinal Vasculitis
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Ophthalmology & Optometry
  • Neurofibromin 2
  • Macular Degeneration
  • Intravitreal Injections
  • Humans
 

Citation

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Khanani, A. M., Brown, D. M., Jaffe, G. J., Wykoff, C. C., Adiguzel, E., Wong, R., … MERLIN Investigators, . (2022). MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid. Ophthalmology, 129(9), 974–985. https://doi.org/10.1016/j.ophtha.2022.04.028
Khanani, Arshad M., David M. Brown, Glenn J. Jaffe, Charles C. Wykoff, Eser Adiguzel, Randall Wong, Xiangyi Meng, Jeffrey S. Heier, and Jeffrey S. MERLIN Investigators. “MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid.Ophthalmology 129, no. 9 (September 2022): 974–85. https://doi.org/10.1016/j.ophtha.2022.04.028.
Khanani, Arshad M., et al. “MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid.Ophthalmology, vol. 129, no. 9, Sept. 2022, pp. 974–85. Pubmed, doi:10.1016/j.ophtha.2022.04.028.
Khanani AM, Brown DM, Jaffe GJ, Wykoff CC, Adiguzel E, Wong R, Meng X, Heier JS, MERLIN Investigators. MERLIN: Phase 3a, Multicenter, Randomized, Double-Masked Trial of Brolucizumab in Participants with Neovascular Age-Related Macular Degeneration and Persistent Retinal Fluid. Ophthalmology. 2022 Sep;129(9):974–985.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

September 2022

Volume

129

Issue

9

Start / End Page

974 / 985

Location

United States

Related Subject Headings

  • Wet Macular Degeneration
  • Treatment Outcome
  • Retinal Vasculitis
  • Recombinant Fusion Proteins
  • Receptors, Vascular Endothelial Growth Factor
  • Ophthalmology & Optometry
  • Neurofibromin 2
  • Macular Degeneration
  • Intravitreal Injections
  • Humans