Use of Aflibercept to Treat Retinopathy of Prematurity in Children with Extremely Low Birth Weight

TL;DR

This study examines the use of aflibercept to treat retinopathy of prematurity in extremely low birth weight infants, showing effective regression with some reactivation cases.

Contribution

The paper provides clinical insights on aflibercept's efficacy and safety in a specific high-risk ROP patient group with extremely low birth weight.

Findings

Aflibercept treatment led to complete regression of ROP in all 11 children.

ROP reactivated in 45% of children, requiring additional laser therapy.

One child developed cataract as a complication, while others had no complications.

Abstract

Background: Aflibercept is one of the anti-VEGF drugs used, among others, for the treatment of retinopathy of prematurity, alongside the widely used bevacizuab and ranibizumab. It is a recombinant fusion protein composed of the human VEGFR-1 and VEGFR-2 domains combined with the Fc part of human IgG, called VEGF-TRAP. The paper describes a group of premature infants treated with aflibercept due to retinopathy of prematurity at the Regional Specialized Children’s Hospital in Olsztyn, Poland, in the years 2017–2019. Methods: Eleven children (22 eyes) with extremely low birth weight and type 1 ROP and A-ROP qualified for treatment. The birth weight of the children was 460–940 g (average 677 g). Children were treated between 32 and 38 weeks of postconceptional age (on average in 33.3 week). We administered 1 mg (0.025 mL) of aflibercept intravitreal to each eye under local anesthesia. Results: In all cases, the retinopathy regressed. Between 2 and 7 weeks after treatment, the disease reactivated in five children (45%) in the form of ROP type 2, and these children underwent retinal laser photocoagulation. One child had a complication in the form of a cataract in one eye, while the remaining children had no complications after the injection and laser therapy. In all children, there was complete regression of ROP, and retinal vascularization was observed up to the end of zone III or up to the border of laser therapy. A child with cataract underwent lensectomy. All children are under the care of our center, and were examined ophthalmologically and strabologically; the results of these tests will be presented in a separate study. Conclusions: Aflibercept differs from other anti-VEGF drugs in its point of action and pharmacodynamics of action. In the literature, its effectiveness is estimated at over 80%, but there are also studies in which the reactivation of ROP after treatment reaches over 40%. In this study, the treated children were characterized by extremely low birth weight and, as a result, numerous complications related to prematurity occurred, such as bronchopulmonary dysplasia, sepsis, anemia, heart defects, and others. Many of them were in the intensive care unit. These factors may influence ROP reactivation and complications. The description compares studies in which aflibercept was administered at the same dose—1 mg. Currently, large studies (e.g., Firefleye and Butterfleye) describe the effects of a new aflibercept therapy at a dose of 0.4 mg. Studies on aflibercept obviously require further observations, so all reports, even from small groups, are important.

Figures