The phase 2 Ladder trial indicated no evidence of worse macular atrophy with PDS compared with intravitreal ranibizumab 0.5-mg injections.
Differences in the rates of macular atrophy may exist between eyes with neovascular age-related macular degeneration (nAMD) treated continuously with the Port Delivery System with ranibizumab (PDS) and those treated with ranibizumab as a bolus intravitreal injection.
However, new findings from the phase 2 Ladder trial indicate no evidence of worse macular atrophy with PDS compared with monthly intravitreal ranibizumab 0.5-mg injections.
“Larger trials focusing on macular atrophy are needed to confirm this finding,” according to study investigator Glenn J. Jaffe, MD, Duke Eye Center, Duke University School of Medicine.
This was performed as a preplanned exploratory analysis of the multicenter, randomized, active treatment–controlled, dose-ranging study. Individuals diagnosed with nAMD within 9 months of screening who received at least 2 previous intravitreal anti-VEGF injections and were responsive to treatment were included in the trial.
The eyes were randomized at 3:3:3:2 to treatment with either PDS filled with a formulation of ranibizumab at 10, 40, or 100 mg/ml and refilled pro re nata or monthly intravitreal ranibizumab 0.5-mg injection. Investigators considered the primary outcome measures as the prevalence, incidence, and progression of macular atrophy.
The population of the analysis included a total of 220 eyes. This was separated into 58, 62, 59, and 41 eyes in the PDS 10-mg/ml, 40-mg/ml, 100-mg/ml, and monthly intravitreal ranibizumab 0.5-mg injection arms, respectively.
At the baseline, macular atrophy was found 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, according to study investigators.
Then, at the final assessment (mean, 22.1 months), investigators noted the prevalence of macular atrophy 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).
For those without macular atrophy at baseline, data show a higher proportion of eyes in the monthly ranibizumab arm (40.6%) developed macular atrophy compared with those in the PDS arms (28.6%, 32.1%, and 30.6% of eyes in the PDS 10-, 40-, and 100-mg/ml arms, respectively).
Additionally, the mean change in area of macular atrophy from baseline to the last assessment for the 3 PDS categories and monthly ranibizumab arms was +2.46, +1.61, +1.09, and +1.15 mm2, respectively.
At the 9-month mark, for patients without macular atrophy at baseline, the difference in incidence of macular atrophy between the PDS 100-mg/ml and monthly ranibizumab groups was reported to be –12% (95% confidence interval [CI], –31% to 7%).
The study, “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,” was published in Ophthalmology Retina.