To evaluate the 52-week safety and efficacy of intravitreal ziv-aflibercept in patients with neovascular age-related macular degeneration.
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.
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.
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: firstname.lastname@example.org
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.