Study Shows Aflibercept Could Impact Endothelium Thickness

A new report has found that use of intravitreal aflibercept may affect corneal endothelium thickness.

Study investigators found that intravitreal administration of aflibercept might alter the corneal endothelium within 6 months of their first injection.

Investigators from the Dokkyo Medical University Saitama Medical Center in Japan examined 46 eyes from 44 consecutive patients in order to determine the effect of intravitreal aflibercept injection on the corneal endothelium. Patients had diabetic macular edema (DME) or cystoid macular edema (CME) caused by retinal vein occlusion (RVO), the investigators said. The patients’ ages ranged from 55 to 88 years and 27 patients were men.

Each of the patients received a single intravitreal aflibercept injection (2 mg in 0.05 mL) followed by pro re nata (PRN) use. Before the first injection, as well as at month 1, 3, and 6, the patients underwent central corneal specular microcopy. The investigators measured endothelial cell density, average cell size, standard deviation of cell size, coefficient of variation of cell size, maximum and maximum of cell size, percentage of hexagonal cells, and central corneal thickness.

While there were no differences observed by the investigators in most of the variables, they noticed that the maximum of cell size measured before the aflibercept injection was slightly different than the values from month 1, 3, and 6. The investigators noted an average of 1.43±0.58 intravitreal aflibercept injections were administered per patient. Among eyes that received multiple injections, the investigators reported an average of 2.11±0.32 injections. They added that there were no systemic or ocular adverse events recorded throughout the 6 month follow-up period.

The investigators then compared results from the DME patients to the patients with CME due to RVO. They did not find any significant differences in any of the parameters they examined, before or after the intravitreal aflibercept injections.

Intraocular pressure (IOP) remained similar before the injection and at months 1, 3, and 6, the investigators said. The study authors compared the mean IOP between treated and untreated eyes and found that the difference at month 1 was the only time period significant: 12.5±2.7 vs 13.6±2.9 mmHg, respectively. There was no statistically significant difference between DME and CME due to RVO patients, they added.

Another study showed that intravitreal aflibercept did not affect corneal endothelium in patients with age-related macular degeneration (AMD), but the investigators wrote that intravitreal aflibercept can stress the corneal endothelial cells of diabetic patients.

One of the limitations of this study was the small sample size, the investigators noted, in addition to the short follow-up period and the low average number of injections.

These injections “might induce corneal endothelial damage or very slight changes in corneal endothelial cells within 6 months of the first injection. Corneal endothelial damage can lead to partial abnormal corneal hydration and, consequently, corneal edema,” the study authors concluded, adding that further research is needed.

The paper, titled “Effect of intravitreal aflibercept on corneal endothelial cells: a 6-month follow-up study,” was published in the journal Clinical Ophthalmology.