For a study, researchers sought to contrast laser photocoagulation with intravitreal aflibercept in newborns with retinopathy of prematurity (ROP) who require therapy.
The 24-week, noninferiority, 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 infants (gestational age ≤32 weeks at birth or birth weight 1,500 g) with ROP severity (zone I stage 1+ [stage 1 plus increased disease activity], zone I stage 2+, zone I stage 3, zone I stage 3+, zone II stage 2+, or zone II stage 3+) requiring treatment or with aggressive posterior ROP in at least 1 eye were enrolled (the last visit occurred on February 12, 2021). At baseline, infants were randomized 2:1 to either 0.4-mg intravitreal aflibercept (n=75) or laser photocoagulation (n=43). Additional therapy was permitted as described. The proportion of newborns without active ROP and unsatisfactory structural results 24 weeks after therapy began was the main endpoint (assessed by investigators). Therapy failure was deemed to have occurred when rescue treatment was necessary. If the lower limit of the 1-sided 95% Bayesian credible interval for the treatment difference was more than −5%, intravitreal aflibercept was judged noninferior.
Among the 118 babies that were randomly assigned, 113 received treatment (mean gestational age, 26.3 [SD, 1.9] weeks; 53 [46.9%] were female; 16.8% had aggressive posterior ROP, 19.5% had zone I ROP, and 63.7% had zone II ROP), and 104 finished the trial. The majority of patients (92.9%) underwent bilateral treatment (intravitreal aflibercept: 75; laser photocoagulation: n=38), and 82.2% of intravitreal aflibercept group participants received 1 injection in each eye. With intravitreal aflibercept, treatment success was 85.5%, compared to 82.1% with laser photocoagulation (between-group difference, 3.4%; 1-sided 95% credible interval, −8.0% to ∞). Rescue therapy was necessary for 4.8% (95% CI, 1.9% to 9.6%) of the eyes treated with intravitreal aflibercept, compared to 11.1% (95% CI, 4.9% to 20.7%) of the eyes treated with laser photocoagulation. The intravitreal aflibercept group experienced significant adverse event rates of 13.3% (ocular) and 24.0% (systemic), compared to 7.9% and 36.8%, respectively, in the laser photocoagulation group. The scientists concluded that three deaths that took place 4 to 9 weeks following intravitreal aflibercept treatment were unconnected to aflibercept.
With regard to the primary outcome of the proportion of babies achieving treatment success at week 24, intravitreal aflibercept did not fulfill the criteria for noninferiority when compared to laser photocoagulation among infants with ROP. For more conclusive findings on the relative effects of intravitreal aflibercept and laser photocoagulation in the cohort, further data would be needed.