Paper 34

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A Phase 1 Dosing Study of Bevacizumab for ROP: 12-month Ocular Outcomes

 Eric R. Crouch, MD; David K. Wallace, MD; Raymond T. Kraker, MSPH; Michael X. Repka, MD; Janine E. Collinge, MD; Michael E. Gray, MD; Paul G. Steinkuller, MD; Don L. Bremer, MD
Jaeb Center for Health Research
Tampa, FL

Introduction:  Infants with type 1 ROP were enrolled into a masked, multi-center, phase 1 dose de-escalation study and treated initially with doses of 0.25 mg, 0.125 mg, 0.063 mg, or 0.031 mg of bevacizumab.  Additional treatment after 4-weeks was at investigator discretion.  Ocular outcomes at 12-months corrected age are reported.

Methods:  Infants were examined at 12-months corrected age.

Results:  Forty-five of 58 infants (76%) completed the outcome exam.  Of 44 study eyes with a cycloplegic refraction, 6 (14%) had myopia > -5.00D spherical equivalent [SE]) and 2 (5%) had hyperopia >+4.00D SE.  Mean SE refractive error was -0.88D.  Abnormalities of the cornea, lens, or anterior segment were reported in 2 (4%), 1 (2%), and 1 (2%) eye(s), respectively.  Optic nerve atrophy was identified in 6 (13%) eyes; 1 (2%) eye had a total retinal detachment. Strabismus at near fixation was present in 13 infants (29%), 7 (16%) had nystagmus and 3 (7%) had amblyopia.  Of 44 study eyes assessed for fixation behavior, 36 (82%) had central, steady, and maintained fixation behavior.

Discussion:  In this study of low dose bevacizumab, the rates of high myopia, strabismus, nystagmus, and other ocular findings at one year were low and consistent with rates reported for higher doses.[1-3]

Conclusion:  A larger comparative study with longer follow-up will be required to better assess the relative risks for developing ocular co-morbidities in infants receiving a lowest effective dose of bevacizumab for Type 1 ROP as determined by this phase 1 study.

[1] 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;155:1119-24.e1.
[2] VanderVeen DK, Coats DK, Dobson V, Fredrick D, Gordon RA, Hardy RJ, et al. Prevalence and course of strabismus in the first year of life for infants with prethreshold retinopathy of prematurity: findings from the Early Treatment for Retinopathy of Prematurity study. Arch Ophthalmol. 2006;124:766-73.
[3] Wheeler DT, Dobson V, Chiang MF, Bremer DL, Gewolb IH, Phelps DL, et al. Retinopathy of prematurity in infants weighing less than 500 grams at birth enrolled in the early treatment for retinopathy of prematurity study. Ophthalmology. 2011;118:1145-51.

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