PDS Implant Equals Monthly Injections for DME
Pagoda Trial: Evaluating a Novel Approach to Treating Diabetic Macular Edema
Table of Contents
- Pagoda Trial: Evaluating a Novel Approach to Treating Diabetic Macular Edema
- Pagoda Trial: Q&A on Novel DME Treatment
- 1. what is the Pagoda Trial?
- 2. What is the Port Delivery System (PDS) for Ranibizumab?
- 3. What were the Primary Findings of the Pagoda Trial?
- 4. what was the Design of the Pagoda Trial?
- 5. Who Led the Pagoda trial?
- 6. What were the Adverse Events Associated with the PDS in the pagoda Trial?
- 7. When was the PDS Approved for DME Treatment in the US?
- 8. What are the Implications of the Pagoda Trial for DME Treatment?
- 9. Did the PDS group experience any initial setbacks in visual acuity?
- 10. Why is Reducing the Frequency of Anti-VEGF Injections Important?
- 11. Pagoda Trial: Key Facts
Published:
The Pagoda randomized clinical trial (NCT04108156) assessed the efficacy and safety of the Port Delivery System (PDS) with ranibizumab (susvimo,Genentech) against monthly injections of ranibizumab (Lucentis,Genentech) for treating diabetic macular edema (DME). The study, led by Arshad M. Khanani, MD, demonstrated comparable visual acuity (VA) improvements with both treatment methods.
The study focused on addressing the challenges of frequent anti-VEGF injections. The pagoda study researchers explained,”Intravitreal anti–vascular endothelial growth factor (VEGF) injections have demonstrated efficacy in improving vision outcomes and quality of life for patients with DME.” However, they also noted that “Frequent treatment is required for optimal outcomes, with injections needed as often as monthly, placing burden on patients, caregivers, and health professionals.”
The trial aimed to determine if continuous delivery of ranibizumab 100 mg/mL via the PDS, exchanged every 24 weeks, could provide noninferior outcomes compared to monthly intravitreal injections of ranibizumab 0.5 mg in DME patients over 64 weeks.
Study Design and Key Findings
This phase 3, multicenter, noninferiority trial involved 87 US sites and included previously untreated patients with centre-involved DME. Participants were randomized in a 3:2 ratio to recieve either four monthly doses of ranibizumab 0.5 mg followed by ranibizumab 100 mg/mL via PDS every 24 weeks, or monthly ranibizumab injections.
The primary endpoint was the change in best-corrected VA (BCVA) from baseline, averaged over weeks 60 and 64.
The study included 634 patients (57.3% men; mean age, 60.7 years), with 381 assigned to the PDS group and 253 to the monthly ranibizumab group.
Results showed a mean BCVA increase of 9.6 letters in the PDS group and 9.4 letters in the monthly ranibizumab group, averaged over weeks 60 and 64. these results confirmed the noninferiority of PDS delivery of ranibizumab.
Notably, the PDS group experienced a 6.7-letter BCVA decrease four weeks post-implantation. However, by week 16, the mean BCVA in the PDS group aligned with that of the monthly ranibizumab group.
Adverse events were more frequent in the PDS group (27.5%) compared to the monthly ranibizumab group (8.9%). No cases of endophthalmitis or retinal detachment were reported in association with PDS insertion. Common adverse events included cataract formation, vitreous hemorrhage, conjunctival bleb/conjunctival filtering bleb leakage, and conjunctival erosion or retraction.
The researchers concluded that the PDS implant “provides effective, durable, and generally well-tolerated treatment for DME with retreatment every 6 months thru at least 64 weeks and was approved in the US for patients with DME in February 2025.”
Implications for Diabetic Macular Edema Treatment
The Pagoda trial suggests that the Port Delivery System (PDS) offers a promising alternative to frequent intravitreal injections for managing diabetic macular edema. By providing continuous ranibizumab delivery, the PDS aims to reduce the treatment burden on patients, caregivers, and healthcare providers.
While adverse events were more common in the PDS group, the absence of severe complications like endophthalmitis or retinal detachment is reassuring. Further studies and real-world data will be crucial to fully understand the long-term safety and efficacy of the PDS in diverse patient populations.
Pagoda Trial: Q&A on Novel DME Treatment
This article addresses frequently asked questions regarding the Pagoda clinical trial and its implications for treating diabetic macular edema (DME).
1. what is the Pagoda Trial?
The Pagoda trial (NCT04108156) was a randomized clinical trial designed to evaluate the effectiveness and safety of the Port delivery System (PDS) with ranibizumab (Susvimo, Genentech) compared to monthly intravitreal injections of ranibizumab (Lucentis, Genentech) in patients with diabetic macular edema (DME). The trial sought to determine if the PDS, which provides continuous delivery of ranibizumab, could offer similar visual acuity improvements as monthly injections, while reducing the frequency of treatments.
2. What is the Port Delivery System (PDS) for Ranibizumab?
The Port Delivery System (PDS) is an implantable device designed for the continuous delivery of ranibizumab, an anti-VEGF medication, into the eye. It is surgically implanted and refilled every 24 weeks (approximately six months). this system aims to reduce the burden of frequent intravitreal injections typically required for managing DME.
3. What were the Primary Findings of the Pagoda Trial?
The Pagoda trial demonstrated that the PDS with ranibizumab was non-inferior to monthly ranibizumab injections in improving visual acuity in patients with DME. The mean change in best-corrected visual acuity (BCVA) from baseline, averaged over weeks 60 and 64, was comparable between the PDS group (9.6 letters) and the monthly injection group (9.4 letters).
4. what was the Design of the Pagoda Trial?
The Pagoda trial was a Phase 3, multicenter, non-inferiority trial conducted at 87 US sites.It involved 634 previously untreated patients with center-involved DME. Participants were randomized in a 3:2 ratio to receive either:
Four monthly doses of ranibizumab 0.5 mg followed by ranibizumab 100 mg/mL via PDS every 24 weeks.
Monthly ranibizumab injections of 0.5 mg.
The primary endpoint was the change in best-corrected visual acuity (BCVA) from baseline,averaged over weeks 60 and 64.The study duration was 64 weeks.
5. Who Led the Pagoda trial?
The Pagoda trial was led by Arshad M. Khanani, MD.
6. What were the Adverse Events Associated with the PDS in the pagoda Trial?
Adverse events were more frequent in the PDS group (27.5%) compared to the monthly ranibizumab group (8.9%). The study reported no cases of endophthalmitis or retinal detachment associated with PDS insertion. Common adverse events included:
Cataract formation
Vitreous hemorrhage
Conjunctival bleb/conjunctival filtering bleb leakage
conjunctival erosion or retraction
7. When was the PDS Approved for DME Treatment in the US?
The Port Delivery System (PDS) with ranibizumab (Susvimo) was approved in the US for the treatment of diabetic macular edema (DME) in February 2025.
8. What are the Implications of the Pagoda Trial for DME Treatment?
The Pagoda trial suggests that the PDS offers a promising choice to frequent intravitreal injections for managing DME. By providing continuous ranibizumab delivery, the PDS aims to reduce the treatment burden on patients, caregivers, and healthcare providers. Although adverse events were more common in the PDS group, the absence of severe complications (like endophthalmitis or retinal detachment) is encouraging.
9. Did the PDS group experience any initial setbacks in visual acuity?
Yes, the PDS group experienced an initial decrease in BCVA of 6.7 letters four weeks post-implantation. However, by week 16, the mean BCVA in the PDS group aligned with that of the monthly ranibizumab injection group.
10. Why is Reducing the Frequency of Anti-VEGF Injections Important?
As stated by the Pagoda study researchers, intravitreal anti-VEGF injections “have demonstrated efficacy in improving vision outcomes and quality of life for patients with DME.” However, “frequent treatment is required for optimal outcomes, with injections needed as often as monthly, placing burden on patients, caregivers, and health professionals.”
11. Pagoda Trial: Key Facts
| Key Aspect | PDS Group (Susvimo) | Monthly Ranibizumab Injections (Lucentis) |
| ———————- | ————————————————– | ————————————————– |
| Treatment Schedule | Ranibizumab via PDS every 24 weeks | Monthly ranibizumab injections |
| BCVA Improvement | 9.6 letters (averaged over weeks 60 and 64) | 9.4 letters (averaged over weeks 60 and 64) |
| Adverse events | 27.5% | 8.9% |
| severe Complications| No endophthalmitis or retinal detachment reported | No endophthalmitis or retinal detachment reported |
| US Approval | February 2025 | N/A |