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52-Week Results

de Oliveira Dias, João R., MD, PhD; Costa de Andrade, Gabriel, MD; Kniggendorf, Vinicius F., MD; Novais, Eduardo A., MD; Takahashi, Vítor K. L., MD; Maia, André, MD, PhD; Meyer, Carsten, MD, PhD; Watanabe, Sung E. S., MD, PhD; Farah, Michel E., MD, PhD; Rodrigues, Eduardo B., MD, PhD

doi: 10.1097/IAE.0000000000002001
Original Study

Purpose: To evaluate the 52-week safety and efficacy of intravitreal ziv-aflibercept in patients with neovascular age-related macular degeneration.

Methods: All patients received three monthly intravitreal injections of 0.05 mL of ziv-aflibercept (1.25 mg) followed by a pro re nata regimen. The best-corrected visual acuity and spectral domain optical coherence tomography were obtained at baseline and monthly. Full-field and multifocal electroretinograms were obtained at baseline and 4, 13, 26, and 52 weeks. For some full-field electroretinography parameters, we calculated the differences between baseline and 52 weeks and then compared those differences between treated and untreated fellow eyes.

Results: Fifteen patients were included and 14 completed the 52-week follow-up. The mean best-corrected visual acuity improved from 0.95 ± 0.41 (20/200) at baseline to 0.75 ± 0.51 (20/125) logarithm of the minimum angle of resolution at 52 weeks (P = 0.0066). The baseline central retinal thickness decreased from 478.21 ± 153.48 μm to 304.43 ± 98.59 μm (P = 0.0004) at 52 weeks. Full-field electroretinography parameters used to assess retinal toxicity after intravitreal injections (rod response and oscillatory potentials) remained unchanged during follow-up. The average multifocal electroretinography macular response in 5° showed increased N1-P1 amplitude and decreased P1 implicit time (P < 0.05). One patient presented with intraocular inflammation after the seventh intravitreal procedure.

Conclusion: The results suggested that intravitreal ziv-aflibercept might be safe and effective for treating neovascular age-related macular degeneration. More patients and a longer follow-up are needed to confirm the long-term outcomes of intravitreal ziv-aflibercept.

Administration of intravitreal injections of ziv-aflibercept (1.25 mg) during 52 weeks according to an as-needed regimen resulted in visual improvement and no electroretinographic signs of toxicity in patients with neovascular age-related macular degeneration.

Department of Ophthalmology, Paulista Medical School, Federal University of São Paulo, São Paulo, Brazil.

Reprint requests: João R. de Oliveira Dias, MD, Department of Ophthalmology, Paulista Medical School, Federal University of São Paulo, Rua Botucatu 821, São Paulo 04023-062, Brazil; e-mail:

Supported by Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP; São Paulo, Brazil), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq; Brasília, Brazil), and Pan-American Association of Ophthalmology/Pan-American Ophthalmological Foundation, Paul Kayser/RRF Global Award (PAAO/PAOF; Arlington, TX).

None of the authors has any conflicting interests to disclose.

© 2019 by Ophthalmic Communications Society, Inc.