Drug-Eluting Device’s Macular Atrophy Incidence Comparable With Injections

Macular atrophy (MA) incidence in eyes treated with continuous ranibizumab delivery through the Port Delivery System (PDS) is comparable with that of eyes given monthly intravitreal ranibizumab injections, according to results published in Ophthalmology Retina. Seeking to determine whether MA rates differ in eyes with neovascular age-related macular degeneration (nAMD), investigators report that there was no evidence of worse MA with the PDS relative to monthly intravitreal ranibizumab 0.5 mg injections. 

The preplanned exploratory analysis of a phase 2, multicenter, randomized, active-treatment-controlled, dose-ranging study measured MA prevalence, incidence, and progression. The study included patients diagnosed within 9 months of screening who had received at least 2 previous intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections of any agent and were responsive to treatment. Analysis consisted of 220 eyes.

“Continuous delivery of ranibizumab through the PDS did not seem to be associated with an increased incidence or enlargement of MA compared with monthly ranibizumab. The proportion of eyes with incident MA and the MA area growth rate trended lower in eyes with PDS 100 mg/ml compared with monthly ranibizumab” say researchers.

At study baseline, MA was in 14.5% (PDS 10 mg/ml), 11.5% (PDS 40 mg/ml), 13.6% (PDS 100 mg/ml), and 7.6% (monthly ranibizumab) of eyes. At last assessment (mean, 22.1 months), MA prevalence had increased to 38.6% (PDS 10 mg/ml), 40.0% (PDS 40 mg/ml), 40.4% (PDS 100 mg/ml), and 45.7% (monthly ranibizumab). 

In patients without MA at baseline, a higher proportion of eyes in the monthly ranibizumab arm (40.6%) developed MA vs PDS arms (28.6%, 32.1%, and 30.6% of eyes in the PDS 10mg/ml, 40 mg/ml, and 100 mg/ml arms, respectively). The mean change in MA area from baseline to last assessment for PDS 10 mg/ml, 40 mg/ml, 100 mg/ml, and monthly ranibizumab arms was +2.46 mm2, +1.61 mm2, +1.09 mm2, and +1.15 mm2, respectively. 

“The reason for this difference is not known and it still remains to be determined whether continuous delivery is associated with lower rates and reduced growth of MA compared with bolus intravitreal injections,” note the study’s authors. These findings suggest the need for further confirmation through larger and more comprehensive trials focusing on MA.

Limitations include the small number of participants, the use of only a few time points, and the lack of a prespecified statistical comparison. 

Disclosure: Some study authors declared affiliations with the biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.

Reference

Jaffe GJ, Cameron B, Kardatzke D, Ives J, Barteselli G, Gune S. Prevalence and progression of macular atrophy in eyes with neovascular age-related macular degeneration in the phase 2 ladder trial of the port delivery system with ranibizumab, Ophthalmol Ret. Published online April 12, 2022. doi:10.1016/j.oret.2022.04.006