Aflibercept Matches Laser for Retinopathy of Prematurity

Laird Harrison

September 21, 2021

Judging from short-term outcomes, aflibercept works at least as well as laser photocoagulation to treat retinopathy of prematurity (ROP), researchers say.

Aflibercept cleared the ROP in slightly more patients than laser did, but the difference was not statistically significant, said Andreas Stahl, MD, a professor of ophthalmology at the University Medical Center Greifswald, in Greifswald, Germany.

"We also had less need for rescue therapy in the aflibercept arm compared to laser, and a reduced requirement for general anesthesia," he said.

Stahl presented the findings of the FIREFLEYE trial at the European Society of Retina Specialists (EURETINA) 2021 meeting. "It is the first randomized, controlled study on aflibercept compared to laser," he said.

Patients with ROP often undergo laser photocoagulation, but this can cause the loss of visual field and the development of high myopia, and it usually requires longer sedation and breathing assistance.

Anti–vascular endothelial growth factor treatments have shown promise in previous trials. The 2011 BEAT-ROP phase 2 trial showed more benefit from bevacizumab than from laser for patients with zone I disease. And the 2019 RAINBOW trial concluded that ranibizumab "might be" superior to laser.

From treating conditions such as neovascular age-related macular degeneration, some researchers have theorized that aflibercept could be more potent than these other drugs, but it also may pose more risk for systemic adverse reactions.

To explore these possibilities, Stahl and his colleagues enrolled 113 infants from Europe, Asia, and South America. Gestational age was ≤32 weeks, or birth weight was ≤1500 g. All patients weighed >800 g at baseline and had an ROP in at least one eye that was classified as zone I, stage 1+, 2+, 3, 3+; zone II, stage 2+, 3+; or aggressive posterior (AP)-ROP.

Of these infants, 75 received a single injection of aflibercept 0.4 mg (0.02 mL) at baseline. Up to two additional injections per eye could be administered if the ROP was present and it had been ≥28 days since the previous injection.

The other 38 infants received transpupillary conventional laser photocoagulation to the entire avascular peripheral retina. Multiple sessions within 1 week of baseline counted as a single treatment. After that, laser re-treatment was allowed if ROP requiring treatment was present and fundus examination revealed that laser treatment was incomplete.

In either arm, infants could receive rescue treatment with the alternate modality if rescue criteria were met. These included worsening or persistence of the ROP.

The treatment was considered successful if the patients had no active ROP or unfavorable structural outcomes (defined as retinal detachment, macular dragging, macular fold, or retrolental opacity) at week 24 after baseline treatment.

By this measure, the success rate was 85.5% in the aflibercept arm and 82.1% in the laser arm overall. The 90% CI was -8.0% to 16.2%, which meant that the difference between the two treatments could be deemed random.

This difference of 3.4 percentage points widened to 6.2 percentage points when the analysis included only patients with zone I ROP excluding AP-ROP. The difference was 6.9 points when the analysis included only those patients with zone II ROP excluding AP-ROP, and it was 1.1 points when only patients with AP-ROP were considered. None of these differences between treatment arms was statistically significant.

In the aflibercept arm, 17.8% of eyes underwent one re-treatment. By contrast, in the laser arm, 6.9% of eyes received one re-treatment after at least a week, and 2.8% received two re-treatments.

On the other hand, 11.1% of eyes in the laser group needed rescue treatment with aflibercept. By comparison, only 4.8% of eyes in the aflibercept group needed rescue treatment with laser.

"Ocular adverse events were in line with what we know from other trials, and systemic adverse events were compatible with the expected comorbidity profiles in these infants," Stahl said.

In the aflibercept group, three infants died, but the investigators did not consider these deaths to be related to the drug.

The researchers plan to continue following these patients until they reach the chronologic age of 5 years.

Those data will be key, said Anat Loewenstein, MD, MHA, chair of the Department of Ophthalmology at Tel Aviv Sourasky Medical Center and professor of ophthalmology at Tel Aviv University, in Tel Aviv, Israel. "These babies tend to develop late sequelae, like retinal detachment, very severe myopia, and so forth," she told Medscape Medical News.

"The study does not give a clear answer what treatment is better, but it just shows that aflibercept is a good treatment," said Loewenstein. Aflibercept could provide another option, particularly in countries where bevacizumab cannot legally be used for this purpose, she said.

Loewenstein has relationships with Allergan, Bayer Healthcare, Beyeonics, ForSight Labs, Notal Vision, Novartis, and Roche. Stahl has relationships with Allergan, Novartis, Bayer, and Roche.

European Society of Retina Specialists (EURETINA) 2021: Presented September 9, 2021.

Laird Harrison writes about science, health, and culture. His work has appeared in magazines, newspapers, and online publications. He is at work on a novel about alternate realities in physics. Harrison teaches writing at the Writers Grotto. Visit him at lairdharrison.com or follow him on Twitter: @LairdH.

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