Clinical Trials in ROP

Retinopathy of prematurity (ROP) affects the developing retina, with approximately 28,300 to 45,600 infants diagnosed globally each year. [Stahl.Lancet.2019] Low birth weight and low gestational age are major risk factors for ROP. [Mirghorbani M.Int J Vitreous Retina.2022] Although mild ROP may resolve on its own, severe ROP can lead to retinal detachment, vision impairment, and blindness. [Stahl.Lancet.2019] Treatments for ROP include lasers, anti-vascular endothelial growth factor (VEGF) injections, and ocular surgery. Laser treatment has been around longer than anti-VEGF injections, but longer-term risks with laser therapy include visual field loss and high myopia. Concerns with anti-VEGF injections include potential systemic exposure to anti-VEGF agents and a higher risk of recurrent ROP compared with laser treatment. [Mirghorbani M.Int J Vitreous Retina.2022]

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Beck KD, Rahman EZ, Ells A, et al. SAFER-ROP: Updated Protocol for Anti-VEGF Injections for Retinopathy of Prematurity. OSLI Retina. 2020;51:402-406.

Cryotherapy for Retinopathy of Prematurity Cooperative Group. Multicenter trial of cryotherapy for retinopathy of prematurity: Preliminary results. Pediatrics. 1988;81: 697-706.

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.

Good WV;  Early Treatment for Retinopathy of Prematurity Cooperative Group. Final results of the Early Treatment of Retinopathy of Prematurity (ETROP) randomized trial. Trans Am Ophthalmol Soc. 2004;102:233-250.

Mintz-Hittner HA, Kennedy KA, Chuang AZ for the BEAT-ROP Cooperative Group. Efficacy of intravitreal bevacizumab for stage 3+ of retinopathy of prematurity. N Engl J Med. 2011;364:603-615.

Mirghorbani M, Rashidinia A, Yaseri M, et al. Progression of retinal vascularization after intravitreal anti-vascular-endothelial growth factor therapy in retinopathy of prematurity. Int J Vitreous Retina. 2022;8:13.

Stahl A, Lepore D, Fielder A, et al. Ranibizumab Versus Laser for the Treatment of Very Low Birthweight Infants With Retinopathy of Prematurity (RAINBOW): An Open-Label Randomised Controlled Trial. Lancet. 2019;394:1551-1559.

Stahl A, Sukgen EA, Wu WC, et al. Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity: The FIREFLEYE Randomized Clinical Trial. JAMA. 2022;328:348-359.

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