OBJECTIVE: The Port Delivery System with ranibizumab (PDS) is approved in the United States for neovascular age-related macular degeneration (nAMD). Portal (NCT03683251) is evaluating long-term safety and tolerability of the PDS in patients with nAMD who completed the phase II Ladder (NCT02510794) or phase III Archway (NCT03677934) trials. DESIGN: Multicenter, nonrandomized, open-label, extension clinical trial. PARTICIPANTS: All-PDS safety population (N = 555) comprises patients enrolled in Portal who completed Ladder or Archway. Because of data availability, efficacy population comprises Ladder-to-Portal patients only: patients who previously received PDS 10, 40, or 100 mg/mL pro re nata (as-needed [PRN]
n = 58, 62, and 59, respectively) or monthly intravitreal ranibizumab 0.5-mg injections (monthly ranibizumab
n = 41) in Ladder and subsequently enrolled in Portal. METHODS: Ladder patients received PDS refill-exchanges PRN or monthly ranibizumab. Archway patients received PDS 100 mg/mL with fixed refill-exchanges every 24 weeks (Q24W) or monthly ranibizumab. Once enrolled in Portal, all patients receive PDS Q24W from day 1. MAIN OUTCOME MEASURES: Ocular adverse events of special interest (AESIs)
changes from baseline in best-corrected visual acuity (BCVA) and center point thickness (CPT)
supplemental ranibizumab treatment between refill-exchange procedures
and PDS Patient Preference Questionnaire results. RESULTS: In the All-PDS safety population (mean follow-up, 111 weeks), 137 (24.7%) patients had ≥1 ocular AESI
most common were cataract (11.4%), vitreous hemorrhage (6.1%), and conjunctival thickening (bleb)/filtering bleb leak (6.3%). Endophthalmitis occurred in 11 of 555 (2.0%) patients. For Ladder-to-Portal patients previously treated with PDS 100 mg/mL or monthly ranibizumab, BCVA remained stable from baseline to month 48
mean (95% confidence interval) changes from baseline were 0.1 (-6.6 to 6.8
n = 31) and 2.3 (-9.4 to 14.1
n = 15) letters, respectively
CPT remained stable through month 48. Approximately 95% of patients did not need supplemental treatment before each refill-exchange for >
2 years since Portal enrollment. Of Ladder-to-Portal previous monthly ranibizumab patients, 92% preferred the PDS over injections. CONCLUSIONS: Interim results from Portal suggest 4-year maintenance of visual/anatomic outcomes with PDS 100 mg/mL, with the PDS preferred to monthly injections. Long-term safety profile of the PDS is well characterized. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.