Clinical Studies:
PAVILLION
Citation: Pieramici DJ, Awh CC, Chang M, et al. Port delivery system with ranibizumab vs monitoring in nonproliferative diabetic retinopathy without macular edema: the pavilion randomized clinical trial. JAMA Ophthalmol. 2025;143(4):317-325.
Key Points
- The PAVILLION study showed that the PDS with ranibizumab provides continuous drug delivery with extended treatment intervals.
- PDS with ranibizumab demonstrated efficacy in improving diabetic retinopathy severity and reducing disease progression.
- PDS with ranibizumab has the potential to reduce treatment burden for patients with diabetic retinopathy.
Study Design
Phase 3, multicenter, randomized, superiority trial. 52 weeks. 50 U.S. locations. Participants were monitored every 4 weeks; PDS recipients underwent refill-exchange procedures every 36 weeks after initial loading doses.
Study Objectives and Endpoints
Primary Objective: Assess the superiority of PDS with ranibizumab (100 mg/mL) over observation in improving diabetic retinopathy severity.
Primary Endpoint: Proportion of participants achieving at least a 2-step improvement on the ETDRS-DRSS at week 52.
Secondary Endpoints: Change in BCVA, change in CST, incidence of ocular adverse events, rate of progression to CI-DME, PDR, or ASNV, and patient-reported outcomes.
Study Subjects
- Total Participants: 174; 106 in the PDS arm and 68 controls.
- Inclusion Criteria:
- Adults aged ≥18 years
- Diagnosis of moderately severe to severe NPDR without CI-DME
- ETDRS-DRSS score of 47 or 53
- Exclusion Criteria:
- History of PDR, CI-DME, or ASNV
- Prior vitrectomy or retinal surgery
- Uncontrolled systemic conditions
Study Eye Inclusion Criteria
- Study eye must meet the inclusion criteria for NPDR without CI-DME
- No prior treatments for diabetic retinopathy in the study eye
- Adequate pupillary dilation and media clarity for retinal imaging
Treatment
- PDS Q36W Group:
- Implantation of PDS containing ranibizumab
- Refill-exchange procedure every 36 weeks
- Control Group:
- Observation with standard of care intravitreal injections as needed
Assessment Methods
- Visual Acuity: ETDRS letter score
- Anatomical Outcomes: Optical coherence tomography (OCT) for CST measurement
- Retinopathy Severity: ETDRS-DRSS
- Adverse Events: Ocular and nonocular adverse events monitored
- Progression Monitoring: Regular retinal imaging and clinical assessments
Results
- Primary Endpoint: PDS Q36W group achieved a significantly higher proportion of participants with at least a 2-step improvement on ETDRS-DRSS (80.1%) compared to the control group (9.0%).
- Visual Acuity: Mean BCVA change from baseline was +1.4 letters in the PDS group and –2.6 letters in the control group.
- CST: Mean CST decreased by 18.8 µm in the PDS group and increased by 2.5 µm in the control group.
- Disease Progression: 7.1% of PDS participants developed CI-DME, PDR, or ASNV, compared to 47.0% in the control group.
- Adverse Events: Ocular adverse events of special interest (cataract, vitreous hemorrhage, conjunctival bleb, conjunctival erosion, conjunctival retraction, hyphema and/or retinal detachment) occurred in 16.2% of PDS participants, with no cases of endophthalmitis or implant dislocation.
Conclusions
- The PDS with ranibizumab demonstrated superior efficacy in improving diabetic retinopathy severity compared to observation.
- Significant reduction in disease progression to CI-DME, PDR, or ASNV was observed in the PDS group.
- PDS offers a potential long-term treatment option with reduced treatment burden.
- Safety profile was consistent with previous studies, with no new safety concerns identified.