TY - JOUR
T1 - Intravitreal Nesvacumab (Anti-Angiopoietin-2) Plus Aflibercept in Neovascular AMD
T2 - Phase 2 ONYX Randomized Trial
AU - Heier, Jeffrey S.
AU - Ho, Allen C.
AU - Boyer, David S.
AU - Csaky, Karl
AU - Vitti, Robert
AU - Perlee, Lorah
AU - Chu, Karen W.
AU - Asmus, Friedrich
AU - Leal, Sergio
AU - Zeitz, Oliver
AU - Cheng, Yenchieh
AU - Schmelter, Thomas
AU - Brown, David M.
N1 - Funding Information:
The authors thank the study investigators and patients involved in the study. Medical writing support was provided by Melissa Purves, PhD, and Nila Bhana, MSc, of Prime (Knutsford, United Kingdom), according to Good Publication Practice guidelines and was funded by Regeneron Pharmaceuticals, Inc. The authors were involved in the study design and collection, analysis, and interpretation of data. All authors had full access to all the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The ONYX trial was funded by Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA. The sponsor participated in the design and conduct of the trial, analysis of the data, and preparation of the manuscript.
Publisher Copyright:
© The Author(s) 2022.
PY - 2023/1/1
Y1 - 2023/1/1
N2 - Purpose: To compare intravitreal nesvacumab (anti-angiopoietin-2) + aflibercept vs intravitreal aflibercept injection (IAI) in neovascular age-related macular degeneration (nAMD). Methods: Eyes were randomized (1:2:3) to nesvacumab 3 mg + aflibercept 2 mg (LD combo), nesvacumab 6 mg + aflibercept 2 mg (HD combo), or IAI 2 mg at baseline, week 4, and week 8. The LD combo was continued every 8 weeks (q8w). At week 12, the HD combo was re-randomized to q8w or every 12 weeks (q12w) and IAI was re-randomized to q8w, q12w, or HD combo q8w through week 32. Results: The study comprised 365 eyes. At week 12, the mean best-corrected visual acuity (BCVA) gains from baseline were similar in the LD combo group, HD combo group, and IAI group (5.2 letters, 5.6 letters, and 5.4 letters, respectively); the mean central subfield thickness (CST) reductions were similar (182.2 µm, 200.0 µm, and 178.6 µm, respectively). The mean changes in BCVA and CST through week 36 were similar across groups. At week 12, complete retinal fluid resolution was observed in 49.1% (LD combo), 50.8% (HD combo), and 43.6% (IAI) of eyes; the proportions with a CST of 300 μm or less were similar across groups. Numerical trends at week 32 toward complete retinal fluid resolution with combination treatment were not maintained at week 36. Serious ocular adverse events were infrequent and comparable across groups. Conclusions: In nAMD, nesvacumab + aflibercept showed no additional BCVA or CST benefit over IAI monotherapy.
AB - Purpose: To compare intravitreal nesvacumab (anti-angiopoietin-2) + aflibercept vs intravitreal aflibercept injection (IAI) in neovascular age-related macular degeneration (nAMD). Methods: Eyes were randomized (1:2:3) to nesvacumab 3 mg + aflibercept 2 mg (LD combo), nesvacumab 6 mg + aflibercept 2 mg (HD combo), or IAI 2 mg at baseline, week 4, and week 8. The LD combo was continued every 8 weeks (q8w). At week 12, the HD combo was re-randomized to q8w or every 12 weeks (q12w) and IAI was re-randomized to q8w, q12w, or HD combo q8w through week 32. Results: The study comprised 365 eyes. At week 12, the mean best-corrected visual acuity (BCVA) gains from baseline were similar in the LD combo group, HD combo group, and IAI group (5.2 letters, 5.6 letters, and 5.4 letters, respectively); the mean central subfield thickness (CST) reductions were similar (182.2 µm, 200.0 µm, and 178.6 µm, respectively). The mean changes in BCVA and CST through week 36 were similar across groups. At week 12, complete retinal fluid resolution was observed in 49.1% (LD combo), 50.8% (HD combo), and 43.6% (IAI) of eyes; the proportions with a CST of 300 μm or less were similar across groups. Numerical trends at week 32 toward complete retinal fluid resolution with combination treatment were not maintained at week 36. Serious ocular adverse events were infrequent and comparable across groups. Conclusions: In nAMD, nesvacumab + aflibercept showed no additional BCVA or CST benefit over IAI monotherapy.
KW - age-related macular degeneration
KW - angiopoietin-2
KW - investigational clinical trials
KW - vascular endothelial growth factor
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U2 - 10.1177/24741264221126061
DO - 10.1177/24741264221126061
M3 - Article
AN - SCOPUS:85156117602
VL - 7
SP - 8
EP - 15
JO - Journal of VitreoRetinal Diseases
JF - Journal of VitreoRetinal Diseases
SN - 2474-1264
IS - 1
ER -