PAVILION
Trial question
What is the effect of port delivery system with ranibizumab in patients with nonproliferative diabetic retinopathy?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
43.0% female
57.0% male
N = 174
174 patients (74 female, 100 male).
Inclusion criteria: adult patients with moderately severe or severe nonproliferative diabetic retinopathy secondary to T1DM or T2DM.
Key exclusion criteria: presence of center-involved diabetic macular edema; intravitreal or periocular corticosteroid treatment; macular laser photocoagulation; active intraocular inflammation; uncontrolled BP; cerebrovascular accident or MI in the past 6 months; AF diagnosis or worsening in the past 6 months; systemic treatment for a confirmed active systemic infection.
Interventions
N=106 port delivery system with ranibizumab (at a dose of 100 mg/mL with fixed refill exchanges every 36 weeks).
N=68 monitoring (study visits every 4 weeks for observation and comprehensive clinical monitoring).
Primary outcome
Proportion of patients with ≥ 2 step improvement in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale at 52 weeks
80.1%
9%
80.1 %
60.1 %
40.0 %
20.0 %
0.0 %
Port delivery system with
ranibizumab
Monitoring
Significant
increase ▲
NNT = 1
Significant increase in the proportion of patients with ≥ 2 step improvement in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale at 52 weeks (80.1% vs. 9%; AD 71.1%, 95% CI 61 to 81.2).
Secondary outcomes
Significant decrease in the rate of rate of development of center-involved diabetic macular edema, proliferative diabetic retinopathy, or anterior segment neovascularization through week 52 (7.1% vs. 47%; HR 0.12, 95% CI 0.05 to 0.28).
Significantly greater improvement in best-corrected visual acuity through week 52 (1.4 letters vs. -2.6 letters; AD 4 letters, 95% CI 0.9 to 7.1).
Significantly greater improvement of ≥ 3-step Diabetic Retinopathy Severity Scale at 52 weeks (15.1% vs. 0%; AD 15.1%, 95% CI 8.3 to 21.9).
Conclusion
In adult patients with moderately severe or severe nonproliferative diabetic retinopathy secondary to T1DM or T2DM, port delivery system with ranibizumab was superior to monitoring with respect to proportion of patients with ≥ 2 step improvement in Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale at 52 weeks.
Reference
Dante J Pieramici, Carl C Awh, Margaret Chang et al. Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema: The Pavilion Randomized Clinical Trial. JAMA Ophthalmol. 2025 Apr 1;143(4):317-325.
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