April 2011
Volume 52, Issue 14
Free
ARVO Annual Meeting Abstract  |   April 2011
Adverse Events After Off Label Intravitreal Bevacizumab In The Treatment Of Retinopathy Of Prematurity
Author Affiliations & Notes
  • Olivia Baldivieso Hurtado
    Retina and Vitreous, Asociacion para Evitar la Ceguera en Mexico, Cuidad de Mexico, Mexico
  • Gerardo García-Aguirre
    Retina and Vitreous, Asociacion para Evitar la Ceguera en Mexico, Cuidad de Mexico, Mexico
  • Virgilio Morales Cantón
    Retina and Vitreous, Asociacion para Evitar la Ceguera en Mexico, Cuidad de Mexico, Mexico
  • Hugo Quiroz-Mercado
    Retina and Vitreous, University of Colorado Hospital, Denver, Colorado
  • R.V. Paul Chan
    Retina and Vitreous, Weill Cornell Medical Center, New York, New York
  • María Ana Martínez-Castellanos
    Retina and Vitreous, Asociacion para Evitar la Ceguera en Mexico, Cuidad de Mexico, Mexico
  • Footnotes
    Commercial Relationships  Olivia Baldivieso Hurtado, None; Gerardo García-Aguirre, None; Virgilio Morales Cantón, None; Hugo Quiroz-Mercado, None; R.V. Paul Chan, None; María Ana Martínez-Castellanos, None
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science April 2011, Vol.52, 3142. doi:
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      Olivia Baldivieso Hurtado, Gerardo García-Aguirre, Virgilio Morales Cantón, Hugo Quiroz-Mercado, R.V. Paul Chan, María Ana Martínez-Castellanos; Adverse Events After Off Label Intravitreal Bevacizumab In The Treatment Of Retinopathy Of Prematurity. Invest. Ophthalmol. Vis. Sci. 2011;52(14):3142.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: : To describe the ocular and systemic adverse events of intravitreal Bevacizumab (IB) used off-label in the treatment of Retinopathy of Prematurity (ROP).

Methods: : Retrospective analysis of the records of 195 patients with ROP (stage 3, threshold, pre-threshold, 4a and 4b) who underwent IB (0.05cc or 0.03cc) in the period from September 2005 to October 2010. Baseline characteristics of each infant and adverse events during and/or after treatment were collected. Follow up of the injection was at least of 3 months.

Results: : We had a total of 52 (26.6%) local adverse events: four (2%) patients with stage 4 had worsening of the retinal detachment, 2 of these required pars plana vitrectomy and final visual outcome was 20/400 or worse. In the beginning of the study the dose we applied was 0.05cc. Since 23 eyes required paracentesis after elevation of intraocular pressure (IOP), we modified the dose to 0.03cc and lowered the IOP elevation rate. Two (1%) patients had peripheral fibrous avascular membrane, 3 (1.5%) intravitreal hemorrhage that resolved without vitrectomy, 8 (4.1%) have avascular extreme periphery, and 12 (6.1%) sub-conjunctival hemorrhage. Systemic adverse events: 3 (1.5%) patients died: one secondary to sepsis by P. aeruginosa 2 months after injection, one by neuro-infection after placement of a ventriculo-peritoneal shunt valve 6 months after injection, and one by multi-organic dysfunction secondary to transfusion blood one week after injection. Twenty two (11.2%) patients had some degree of psychomotor development retardation, after birth and before the injection; 14 patients (7.1%) presented apnea and 6 (3%) respiratory distress syndrome, 1 patient (0.5%) had Down’s syndrome and 1 (0,5%) dysmorphic syndrome.

Conclusions: : The use of IB appears to be safe and effective for type 1 prethreshold and threshold ROP, presenting with a limited number of treatable ocular adverse events. However, once the retina is detached (Stage 4a or worse) retinal detachment may be more likely to progress. With regard to systemic adverse events, we believe that systemic abnormalities in children treated with IB for ROP may be a sequelae of prematurity itself and not related to the medication. Longer follow up is needed of prospective multicenter studies to determine the safety profile for the use of IB in treatment requiring ROP.

Keywords: retinopathy of prematurity • vascular endothelial growth factor • clinical (human) or epidemiologic studies: outcomes/complications 
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