Patients who receive a drug-eluting implant for the management of neovascular age-related macular degeneration (nAMD) are able to maintain stable visual acuity for at least 10-weeks after surgery, according to a poster presented at the American Society of Retina Specialists. The poster details the current status of the SUMMIT study, an ongoing multi-center retrospective investigation evaluating the ranibizumab delivery device.
The Port Delivery System (PDS) is designed to reduce the treatment burden for patients whose treatment protocols include frequent intravitreal injections. The implanted device provides a 100 mg/mL dose of the anti-vascular endothelial growth factor (VEGF); it was approved by the Food and Drug Administration (FDA) for use in October, 2021.
Although the study is ongoing, the presenters report that both visual acuity and central subfield thickness were stable at 10 weeks.
This investigation is evaluating the PDS implant in 8 participants (mean age 83 years, range 74-91 years, 5 men 3 women). In particular, researchers are looking at the participants’ best-corrected visual acuity changes from baseline, changes to central subfield thickness values, any instances of subretinal or intraretinal fluid, adverse events related to the implantation, and the need for supplementary ranibizumab 0.5 mg injections.
The researchers note 5 adverse events have been seen in 6 of the study’s 8 participants–subconjunctival heme (3 patients), Descemet’s folds (2 patients), C/S bleb formation (1 patient), moderate low IOP (2 patients), and anterior chamber cells (3 patients). However, the 3 subconjunctival hemes and 2 Descemet folds have resolved, as have 2 of the 3 cases of anterior chamber cells.
The researchers identified no cases of endophthalmitis, conjunctival retraction or erosion. Participants in the ongoing research will continue to receive ranibizumab refills every 24 weeks, according to the poster.
Khan H, Ewing T, Aziz AA. Real-world efficacy and safety of the ranibizumab port-delivery system in neovascular AMD: the SUMMIT study. Poster presented at: The 40th annual meeting of the American Society of Retina Specialists; June 13-16, 2022; New York. Poster 103.