Four-year clinical trial results indicate that vision and anatomical improvements achieved with the Port Delivery Platform with ranibizumab were maintained in patients with diabetic macular oedema (DMO).
Investigator Dr Luke Lindsell presented the findings at the American Society of Retina Specialists 2026 Annual Meeting.1
The Phase 3 PAGODA enrolled 634 patients with centre-involved DMO who were treatment-naïve or had received no treatment during the preceding six months. Participants were randomised 3:2 to the Port Delivery Platform with ranibizumab 100 mg/mL, refilled every 24 weeks, or intravitreal ranibizumab 0.5 mg every four weeks. Patients in the injection group subsequently crossed over to the implant.
The study’s primary endpoint had previously demonstrated that treatment with the implant every 24 weeks was non-inferior to monthly ranibizumab injections, based on the change in best-corrected visual acuity averaged over weeks 60 and 64.
At week 208, adjusted mean best-corrected visual acuity had increased from baseline by 9.4… letters in the original implant group and 7.7 letters in the crossover group
Four-Year Outcomes
At week 208, adjusted mean best-corrected visual acuity had increased from baseline by 9.4 Early Treatment Diabetic Retinopathy Study (ETDRS) letters in the original implant group and 7.7 letters in the crossover group.
Adjusted mean central subfield thickness decreased by 211 µm and 221 µm, respectively.
A two-step or greater improvement on the Diabetic Retinopathy Severity Scale was recorded in 46.5% of the original implant group and 46.1% of the crossover group at four years.
At week 208, 75.4% of patients in the original implant group and 72.2% of crossover patients had visual acuity equivalent to 20/40 or better.
Approximately 95% of patients did not receive supplemental treatment during each refill-exchange interval. The presentation reported that crossover patients maintained their visual acuity and central subfield thickness improvements after changing from monthly injections to the implant.
Safety Findings
The safety analysis included 559 patients who received an implant, with a mean treatment duration of 3.4 years.
Ocular adverse events of special interest were reported in 256 patients, or 45.8%, while 45 patients, or 8.1%, experienced a serious ocular adverse event of special interest.
Reported events included cataract in 27.0% of patients, subconjunctival fibrosis or fluid in 13.8%, vitreous haemorrhage in 11.3%, conjunctival erosion in 3.4%, hyphema in 3.0%, conjunctival retraction in 2.3%, endophthalmitis in 1.1%, and retinal detachment in 1.1%.
The presentation reported no new safety signals at four years. It concluded that outcomes among crossover patients, who received an average of 16 intravitreal ranibizumab injections before implantation, were consistent with those among patients implanted after four injections.
The Port Delivery Platform with ranibizumab is approved in the United States for adults with neovascular age-related macular degeneration, DMO or diabetic retinopathy who have previously responded to at least two anti-vascular endothelial growth factor injections. It is not approved outside the US.
Reference
- Lindsell LB, Pieramici DJ, Tian K, et al. Pagoda trial results through year 4: port delivery platform with ranibizumab for the treatment of diabetic macular edema [conference presentation]. 44th Annual Scientific Meeting of the American Society of Retina Specialists; 2026; Montréal (QC), Canada. Available at: medically.roche.com/global/en/ophthalmology/asrs-2026/medical-material/ASRS-2026-presentation-lindsell-pagoda-trial-results-through-year-4-pdf.html [accessed Aug 2026].
