Laser photocoagulation provides better outcomes against retinopathy of prematurity: JAMA

Japan: In a new study conducted by Andreas Stahl and team, it was shown that in babies with retinopathy of prematurity (ROP), intravitreal aflibercept did not fulfil criteria for noninferiority with regards to infants attaining treatment success at week 24 when compared to laser photocoagulation. The findings of this study were published in the Journal of American Medical Association (JAMA). 

The conventional therapy for retinopathy of prematurity, laser photocoagulation, can cause complications. Anti-vascular endothelial growth factor injections have been shown in trials to be effective in the treatment of ROP, although few research have directly compared them to laser therapies. As a result, this trial compared intravitreal aflibercept versus laser photocoagulation in newborns with ROP who needed therapy.

This randomized clinical study was done in 27 countries (64 hospital sites) in Asia, Europe, and South America. Between September 25, 2019, and August 28, 2020, 118 children with ROP severity needing treatment or with aggressive posterior ROP in at least one eye were recruited. At baseline, infants were randomly assigned to either 0.4-mg intravitreal aflibercept (n = 75) or laser photocoagulation (n = 43). Additional therapy was permitted as described. The proportion of babies having active ROP and unsatisfactory structural outcomes 24 weeks after commencing therapy was the main endpoint (assessed by investigators). 

The key findings of this study were as follows:

1. Among the 118 infants that were randomly assigned, 113 were treated and 104 finished the trial.

2. The majority of eyes (92.9%) got bilateral treatment, while 82.2% of eyes in the intravitreal aflibercept group had one injection per eye.

3. Treatment success with intravitreal aflibercept was 85.5%, compared to 82.1% with laser photocoagulation.

4. Rescue therapy was required in 4.8% of the eyes treated with intravitreal aflibercept vs 11.1% of the eyes treated with laser photocoagulation.

5. The intravitreal aflibercept group had 13.3% (ocular) and 24.0% (systemic) major adverse event rates, compared to 7.9% and 36.8%, respectively, in the laser photocoagulation group.

6. The scientists determined that three fatalities that occurred 4 to 9 weeks following intravitreal aflibercept therapy were unrelated to aflibercept.

Reference: 

Stahl, A., Sukgen, E. A., Wu, W.-C., Lepore, D., Nakanishi, H., Mazela, J., Moshfeghi, D. M., Vitti, R., Athanikar, A., Chu, K., Iveli, P., Zhao, F., Schmelter, T., … Delbeke, P. (2022). Effect of Intravitreal Aflibercept vs Laser Photocoagulation on Treatment Success of Retinopathy of Prematurity. In JAMA (Vol. 328, Issue 4, p. 348). American Medical Association (AMA). https://doi.org/10.1001/jama.2022.10564