Continuous administration of ranibizumab with a port delivery system provides an alternative to frequent intravitreal injections for diabetic macular edema and helps delay progression of nonproliferative diabetic retinopathy, researchers have found.
Data from two phase 3 trials — Pagoda and Pavilion — demonstrate how the delivery system, which the US Food and Drug Administration approved for diabetic macular edema in February, can reduce treatment burden for select patients, according to Arshad M. Khanani, MD, MA, director of Clinical Research at Sierra Eye Associates and clinical professor at the University of Nevada, Reno School of Medicine.
The findings, published in JAMA Ophthalmology, show how “continuous delivery of anti-VEGF [vascular endothelial growth factor] can really benefit patients with diabetic eye disease,” Khanani, who led the Pagoda trial, told Medscape Medical News.
The Pagoda trial involved 634 patients with diabetic macular edema who received ranibizumab (100 mg/mL) by port refilled every 24 weeks or monthly intravitreal ranibizumab injections (0.5 mg).
At week 64, mean gains in best corrected visual acuity were 9.6 letters in the port group and 9.4 letters in the injection group, confirming noninferiority, according to the researchers.
Adverse events of special interest, including conjunctival blebs and vitreous hemorrhage, were more common in the port group (27.5% vs 8.9%). Transient vision loss was also observed in the port group, with a mean decrease in best corrected visual acuity of 6.7 letters. Although no cases of endophthalmitis were reported in the first 64 weeks of the Pagoda trial, Khanani said some cases have occurred in the second year, mostly due to contamination during the refill exchange procedure.
The Pavilion trial involved 174 patients with moderately severe to severe nonproliferative diabetic retinopathy without center-involved macular edema. Patients received the port delivery system refilled every 36 weeks or standard-of-care monitoring without anti-VEGF treatment.
By week 52, 80.1% of port patients had at least a two-step improvement on the diabetic retinopathy severity scale compared with 9% of those in the control group. Rates of participants developing center-involved macular edema, progressive diabetic retinopathy, or anterior segment neovascula