Macular Atrophy-Related Observations in Eyes Treated with the Port Delivery System with Ranibizumab in the Archway...

To compare the development of macular atrophy (MA) in eyes treated with the Port Delivery System with ranibizumab (PDS) with those treated with monthly intravitreal ranibizumab injections in the Archway trial.

Preplanned exploratory analysis of a phase III, open-label, randomized trial.

Patients with neovascular age-related macular degeneration (nAMD) diagnosed within 9 months of screening, previously treated with and responsive to anti-VEGF therapy.

Eyes were randomized 3:2 to treatment with the PDS 100 mg/ml with fixed 24-week (Q24W) refill-exchanges (PDS Q24W) or intravitreal ranibizumab 0.5 mg injections every 4 weeks (monthly ranibizumab).

Prevalence, incidence, and progression of MA.

The analysis population consisted of 415 eyes (248 and 167 eyes in the PDS Q24W and monthly ranibizumab arms, respectively). At the study baseline, MA was observed in 22.3% (PDS Q24W) and 20.4% (monthly ranibizumab) of eyes. At week 96, the prevalence of MA was 39.1% and 39.2%, whereas the incidence of new MA in eyes without MA at baseline was 20.0% and 22.6% in the PDS Q24W and monthly ranibizumab arms, respectively. In eyes without baseline MA, the mean MA area at week 96 was 0.4 in the PDS Q24W arm and 3.8 mm² in the monthly ranibizumab arm with a difference of 3.4 mm², (P = 0.054) favoring the PDS. In eyes with baseline MA, the mean change in MA area from baseline to week 96 was +2.2 mm² for both the PDS Q24W and monthly ranibizumab arms.

In the Archway trial, which compared PDS Q24W with monthly ranibizumab injections for nAMD treatment over 2 years, the prevalence and incidence of MA were similar between arms over the study duration. In eyes without baseline MA, PDS-treated eyes had less MA area by 3.4 mm², a potentially clinically meaningful (although not statistically significant) difference. The results of this prespecified exploratory analysis suggest that PDS treatment is not associated with a higher incidence or progression of MA when compared with monthly injections of ranibizumab. In eyes without baseline MA, the progression of the atrophy area was 4 times less in PDS-treated eyes. Additional studies could further elucidate this observation.

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