Ranibizumab reported safe for bilateral macular degeneration

Clinicians may safely use ranibizumab 0.5 mg in patients with bilateral age-related macular degeneration (AMD) as well as those with best-corrected visual acuity (BCVA) of less than 2/10, an Italian real-life study suggests.

Clinicians may safely use ranibizumab 0.5 mg in patients with bilateral age-related macular degeneration (AMD) as well as those with best-corrected visual acuity (BCVA) of less than 2/10, an Italian real-life study suggests.

“[The] results confirm the good safety and tolerability profile of ranibizumab 0.5 mg, in both unilaterally and bilaterally treated, mostly elderly patients,” reported Francesco Bandello and colleagues at University Vita Salute Hospital San Raffaele, Milan, Italy. They published their findings in the British Journal of Ophthalmology.

Patients suffering from AMD have around a 50% risk of requiring treatment in both eyes. However, most clinical trials of drugs are conducted on only one eye per patient. Because of the lack of information about the safety of common AMD treatments such as ranibizumab 0.5 mg (Lucentis; Novartis/Genentech) when applied to both of a patient’s eyes, the Italian Medicines Agency (AIFA) initially limited reimbursement for bilateral treatments. 

Recently, on the back of ranibizumab’s approval in new indications, the agency lifted these limitations, as well as limitations on reimbursement for treatment of patients with BCVA of less than 2/10. The TWEYEs study was conducted to assess the safety of the anti-VEGF drug in these specific subgroups by assessing the likelihood of adverse events when using ranibizumab.

Multicentre study

The study enrolled 941 patients in 107 centres in Italy between March 2014 and June 2016. A total of 774 patients completed the study, all of whom were aged 50 or older and had a BCVA of less than 2/10 in the best corrected eye.

Patients with ocular complications such as glaucoma were excluded, as well as pregnant or child-bearing women and those with child-bearing potential who were not using effective contraceptives during the study period.
Patients received one injection per month until they had achieved maximal BCVA or until no signs of the disease remained.

Patients who had recovered were monitored monthly for a return of symptoms for the duration of the 12-month study. If the symptoms returned, participating clinicians resumed the treatment.

Just over half of the patients (534; 57%) had unilateral neovascular AMD (nAMD), while 399 (42.6%) had bilateral nAMD, and three (0.3%) patients did not suffer from nAMD (but had choroidal neovascularization (CNV) secondary to pathological myopia). 823 patients (including all 534 patients with unilateral nAMD, 286 of the patients with bilateral nAMD and the three patients with CNV) were treated unilaterally. 57 were treated bilaterally and the remaining 56 were treated unilaterally until the other eye developed the disease, at which point they were switched to bilateral therapy.

Adverse events

A total of 167 ocular adverse events occurred in 127 eyes over the course of the study. Researchers deemed three of these to be serious in nature. In addition, researchers observed a total of 255 systemic drug-related adverse events in 157 patients over the course of the study.

Most of these (209) occurred in 132 unilaterally treated patients, while 25 bilaterally treated patients suffered a total of 46 adverse events. Researchers determined that 60 of the systemic adverse events were serious. Of these, 51 occurred in unilaterally treated patients, while nine occurred in bilaterally treated patients.

There were nine deaths reported among the study population, but investigators determined that none of them were caused by the drug. The relatively low number of adverse events was consistent with other European studies on the safety of ranibizumab 0.5 mg.

Researchers were encouraged by the low overall number adverse events observed, however, they noted that more research is needed using a larger sample size.