Ranibizumab Safe, Effective Versus Laser Therapy for Retinopathy of Prematurity

By Lisa Rapaport

September 09, 2021

(Reuters Health) - Patients with retinopathy of prematurity are less likely to experience structural ocular abnormalities or myopia when they're treated with ranibizumab 0.2 mg than when they receive laser therapy, a new study suggests.

Researchers examined data on 153 infants who completed a randomized trial of the safety and efficacy of ranibizumab versus laser therapy for retinopathy of prematurity in very low birthweight infants (less than 1,500 g) and were enrolled in an extension trial. Children in the extension study had ophthalmic, development, and health assessments when they were 20 to 28 months old, corrected for prematurity.

The primary outcome of the new analysis was the absence of structural ocular abnormalities. No children developed new ocular structural abnormalities; one child (2%) in the ranibizumab 0.2 mg group and one child (2%) in the laser therapy group had structural abnormalities present.

Compared with laser therapy, the odds ratio of no structural abnormalities was significantly higher with ranibizumab 0.2 mg (OR 5.68), as well as with ranibizumab 0.1 mg (OR 4.82).

The odds of no structural abnormalities were also significantly higher with ranibizumab 0.2 mg than with ranibizumab 0.1 mg (OR 1.21).

In addition, high myopia, which researchers defined as -5 diopters or worse, was seen in a smaller proportion of patients who received ranibizumab 0.2 mg (5%) than among those who received laser therapy (20%).

"No late ocular complications affecting vision were seen and infants exposed to ranibizumab had lower rates of myopia," the study team writes in The Lancet Child & Adolescent Health.

Laser therapy and ranibizumab patients also had similar frequency of strabismus, nystagmus, abnormal fixation, and abnormal pupil reaction, the study found.

Two children on ranibizumab had adverse ocular events, which included one case of swelling of the eyelid and one case of conjunctivitis.

The two children with ocular structural abnormalities - one in the ranibizumab group and one in the laser therapy group - had retinal detachment during the original trial period. One of the two had a recurrence during the follow-up analysis that was treated with vitrectomy surgery and had normal muscular structure at 1 year and 2 years old.

One limitation of the new analysis is that the original trial was powered based on 24-week outcomes, leaving the new analysis to assess long-term descriptive outcomes.

Like other follow-on studies, the current analysis also had high attrition rates. Particularly with preterm infants, socioeconomic status can influence drop-out rates and this wasn't measured in the study, the authors note.

However, anti-VEGF treatment ranibizumab wasn't associated with any serious adverse events and the current analysis raised no concerns about long-term safety, the study team concludes.

"No effects of ranibizumab were detected on neuro-development, growth, blood pressure, or respiratory symptoms," the study team writes.

SOURCE: https://bit.ly/3ts8vHG The Lancet Child & Adolescent Health, online August 12, 2021.