Purpose: To study the structural, visual and refractive outcomes of intravitreal injection of aflibercept monotherapy in patients with high-risk prethreshold type 1 retinopathy of prematurity (ROP). Design: Prospective nonrandomized interventional case series study. Patients and Methods: 1 mg/0.025 ml intravitreal aflibercept was administered for patients with high-risk prethreshold type 1 ROP. The primary outcomes studied were unfavorable structural outcome, unfavorable visual outcome and unfavorable refractive outcome. The secondary outcomes were absence of recurrence, ocular and systemic adverse events. Results: Twenty-six eyes were enrolled in the study; all had completed 1 year of follow-up. The mean birth weight was 991 ± 266 g (range: 875-1,105 g); the mean gestational age at birth was 26.33 ± 2.1 weeks (range: 24-30 weeks); 9 eyes were graded as ROP with stage 2+, zone I retinopathy, 14 eyes had stage 3+ disease in zone II and 3 eyes were diagnosed with stage 3 disease in zone I. Twenty-five eyes (96.2%) showed a favorable structural and 21 (80.1%) a favorable visual outcome, and the median refractive error after 1 year was 0.75 dpt (range: -9.5 to +4). Conclusions: Intravitreal injection of aflibercept monotherapy is an easy, safe and effective alternative modality of therapy for high-risk prethreshold type 1 ROP. A further multicenter study with a longer duration of follow-up is required. © 2014 S. Karger AG, Basel

Palmer EA, Flynn JT, Hardy RJ, Phleps DL, Phillips CL, Schaffer DB, et al: Incidence and early course of retinopathy of prematurity. Ophthalmology 1991;11:1628-1640.
Cryotherapy for Retinopathy of Prematurity Cooperative Group: Multicenter trial of cryotherapy for retinopathy of prematurity. Preliminary results. Arch Ophthalmol 1988;106:471-479.
Palmer EA, Hardy RJ, Dobson V, et al; Cryotherapy for Retinopathy of Prematurity Cooperative Group: 15-year outcomes following threshold retinopathy of prematurity: final results from the multicenter trial of Cryotherapy for Retinopathy of Prematurity. Arch Ophthalmol 2005;123:311-318.
Laser ROP Study Group: Laser therapy for retinopathy of prematurity. Arch Ophthalmol 1994;112:154-156.
Axer-Siegel R, Maharshak I, Snir M, Friling R, Ehrlich R, Sherf I, et al: Diode laser treatment of retinopathy of prematurity. Anatomical and refractive outcomes. Retina 2008;28:839-846.
Early Treatment for Retinopathy of Prematurity Cooperative Group: Revised indications for the treatment of retinopathy of prematurity: results of the Early Treatment for Retinopathy of Prematurity randomized trial. Arch Ophthalmol 2003;121:1684-1694.
Kwinta P, Bik-Multanowski M, Mitkowska Z, Tomasik T, Pietrzyk JJ: The clinical role of vascular endothelial growth factor (VEGF) system in the pathogenesis of retinopathy of prematurity. Graefes Arch Clin Exp Ophthalmol 2008;246:1467-1475.
Kim J, Kim SJ, Chang YS, Park WS: Combined intravitreal bevacizumab injection and zone I sparing laser photocoagulation in patients with zone I retinopathy of prematurity. Retina 2014;34:77-82.
Harder BC, Schlichtenbrede FC, von Baltz S, Jendritza W, Jendritza B, Jonas JB: Intravitreal bevacizumab for retinopathy of prematurity: refractive error results. Am J Ophthalmol 2013;155:1119-1124.
Mintz-Hittner HA, Kennedy KA, Chuang AZ; BEAT-ROP Cooperative Group: Efficacy of intravitreal bevacizumab for stage 3 retinopathy of prematurity. N Engl J Med 2011;364:603-615.
Castellanos MA, Schwartz S, García-Aguirre G, Quiroz-Mercado H: Short-term outcome after intravitreal ranibizumab injections for the treatment of retinopathy of prematurity. Br J Ophthalmol 2013;97:816-819.
Orozco-Gómez LP, Hernández-Salazar L, Moguel-Ancheita S, Ramírez-Moreno MA, Morales-Cruz MV: Laser-ranibizumab treatment for retinopathy of prematurity in umbral-preumbral disease. Three years of experience. Cir Cir 2011;79:207-214, 225-232.
Autrata R, Senková K, Holousová M, Krejcírová I, Dolezel Z, Borek I: Effects of intravitreal pegaptanib or bevacizumab and laser in treatment of threshold retinopathy of prematurity in zone I and posterior zone II - four years results. Cesk Slov Oftalmol 2012;68:29-36.
Autrata R, Krejcírová I, Senková K, Holoušová M, Doležel Z, Borek I: Intravitreal pegaptanib combined with diode laser therapy for stage 3+ retinopathy of prematurity in zone I and posterior zone II. Eur J Ophthalmol 2012;22:687-694.
Papadopoulos N, Martin J, Ruan Q, et al: Binding and neutralization of vascular endothelial growth factor (VEGF) and related ligands by VEGF Trap, ranibizumab and bevacizumab. Angiogenesis 2012;15:171-185.
Brown DM, Heier JS, Clark WL, Boyer DS, Vitti R, Berliner AJ, Zeitz O, Sandbrink R, Zhu X, Haller JA: Intravitreal aflibercept injection for macular edema secondary to central retinal vein occlusion: 1-year results from the phase 3 COPERNICUS Study. Am J Ophthalmol 2013;155:429-437.
Holash J, Davis S, Papadopoulos N, et al: VEGF-Trap: a VEGF blocker with potent antitumor effects. Proc Natl Acad Sci USA 2002;99:11393-11398.
Royal College of Pediatrics and Child Health and Royal College of Ophthalmologists: Retinopathy of prematurity guideline. May 2008. http://www.rcophth.ac.uk/core/.
Royal College of Ophthalmologists: Guideline of intravitreal injection by Royal College of Ophthalmologists. February 2009. http://www.rcophth.ac.uk/core.
Dobson V, Quinn GE, Biglan AW, et al: Acuity card assessment of visual function in the Cryotherapy for Retinopathy of Prematurity trial. Invest Ophthalmol Vis Sci 1990;31:1702-1708.
Stewart MW, Rosenfeld PJ, Penha FM, Wang F, Yehoshua Z, Bueno-Lopez E, Lopez PF: Pharmacokinetic rationale for dosing every 2 weeks versus 4 weeks with intravitreal ranibizumab, bevacizumab, and aflibercept (vascular endothelial growth factor Trap-eye). Retina 2012;32:434-457.
Meyer CH, Krohne TU, Holz FG: Intraocular pharmacokinetics after a single intravitreal injection of 1.5 mg versus 3.0 mg of bevacizumab in humans. Retina. 2011;31:1877-1884.
Foroozan R, Connolly BP, Tasman WS: Outcomes after laser therapy for threshold retinopathy of prematurity. Ophthalmology 2001;108:1644-1646.
The Early Treatment for Retinopathy of Prematurity Group; Good WV, Hardy RJ, Dobson V, et al: Final visual acuity results in the Early Treatment for Retinopathy of Prematurity Study. Arch Ophthalmol 2010;128:663-671.
Sahni J, Subhedar NV, Clark D: Treated threshold stage 3 versus spontaneously regressed subthreshold stage 3 retinopathy of prematurity: a study of motility, refractive, and anatomical outcomes at 6 months and 36 months. Br J Ophthalmol 2005;89:154-159.
Bourla DH, Gonzales CR, Valijan S, Yu F, Mango CW, Schwartz SD: Association of systemic risk factors with the progression of laser-treated retinopathy of prematurity to retinal detachment. Retina 2008;28(suppl 3):S58-S64.
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