Aflibercept in the treatment of diabetic macular edema: a review and consensus paper

Eur J Ophthalmol 2017; 27(6): 627 - 639

Article Type: REVIEW

DOI:10.5301/ejo.5001053

Authors

Avitabile, Teresio Azzolini, Claudio Bandello, Francesco Boscia, Francesco De Falco, Sandro Fornasari, Diego Lanzetta, Paolo Mastropasqua, Leonardo Midena, Edoardo Ricci, Federico Staurenghi, Giovanni Varano, Monica

Abstract

Purpose

To reach a consensus, among experts, on the role of aflibercept in diabetic macular edema (DME) through literature review.

Methods

Two round tables, involving 12 Italian experts, were organized: in the first one, 6 pharmacologic and clinical questions were selected and analyzed by a systematic literature review, using a population, intervention, control, and outcomes framework; in the second one, the nominal group technique was used to discuss relevant evidence related to each question. The consensus was assessed using the 5-point Delphi score.

Results

Agreement on statements was reached on 6/6 questions. The final statements were as follows: 1) High levels of both vascular endothelial growth factor (VEGF) and placental growth factor play an important role in the pathogenesis of DME. 2) The aflibercept pharmacologic profile is notably different from that of other anti-VEGF. 3) Aflibercept significantly improves functional and anatomical outcomes, and rapidly improves best-corrected visual acuity up to its peak; these results remain stable over time. 4) Diabetic macular edema aflibercept treatment requires a 5-monthly injection loading phase. Alternatively, a personalized pro re nata (PRN) regimen based on monthly monitoring and strict retreatment criteria can be used. 5) As an alternative to the bimonthly fixed regimen, in the maintenance phase the treatment schedule may be a PRN regimen with strict retreatment criteria or a treat and extend regimen. 6) No concerns on aflibercept ocular and systemic safety emerged from the literature.

Conclusions

Consensus was reached among experts on how to best treat patients with DME with aflibercept.

Article History

Disclosures

Financial support: No financial support was received for this submission.
Conflict of interest: Teresio Avitabile receives remuneration for participation on advisory boards of Bayer, Novartis, Sifi, and Allergan. Claudio Azzolini has received research funding. Francesco Bandello is a consultant for or receives remuneration for participation on advisory boards of Alcon, Allergan, Alimera Science, Bayer, Bausch & Lomb, Boehringer-Ingelheim, Farmila Thea, Genentech, Hofmann La Roche, Novagali Pharma, Novartis, Sanofi Aventis, Santen, Sifi, Sooft, Thrombogenics, and Zeiss. Francesco Boscia is a consultant of Bayer, Novartis, Allergan, Alcon, and Pfenex. Sandro De Falco is a consultant of Abbott Diagnostics and receives remuneration for participation on the advisory board of Bayer. Diego Fornasari is a consultant of Angelini, Bayer, Grunenthal, Alfa-Sigma, Teva, and Molteni. Paolo Lanzetta is a consultant of Bayer, Genentech, Novartis, and Roche. Leonardo Mastropasqua and Edoardo Midena have no conflicts of interest. Federico Ricci receives personal honoraria for clinical trials, advisory board participation, meeting participation as speaker, and consultancies: PTV Foundation; research grants; Bayer. Giovanni Staurenghi is a consultant from or receives remuneration for participation on advisory boards of Heidelberg Engineering, Quantel Medical, Carl Zeiss Meditec, Alcon, Allergan, Bayer, Boehringer, Genentech, GSK, Novartis, and Roche; receives grant support from Heidelberg Engineering, Optos, Optovue, Quantel Medical, and Centervue; receives lecture fee from Alcon, Allergan, Bayer, GSK, Novartis, and Roche; and receives patents/royalty from Ocular Instruments. Monica Varano receives remuneration for participation on advisory boards of Bayer, Novartis, Sifi, and Allergan.

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