Port Delivery System With Ranibizumab vs Monitoring in Nonproliferative Diabetic Retinopathy Without Macular Edema:...

Area of Science:

• Ophthalmology
• Retinal Diseases
• Diabetic Retinopathy

Background:

• Frequent intravitreal anti-VEGF injections are standard for nonproliferative diabetic retinopathy (NPDR).
• A continuous drug delivery system could reduce treatment frequency.
• The Port Delivery System (PDS) offers sustained intraocular ranibizumab release.

Purpose of the Study:

• To evaluate the efficacy and safety of the Port Delivery System (PDS) with ranibizumab every 36 weeks (PDS Q36W) versus no PDS in moderately severe to severe NPDR without center-involved diabetic macular edema (CI-DME).

Main Methods:

• A randomized clinical trial involving 174 participants with NPDR.
• Participants were randomized to PDS Q36W or a control group.
• Primary outcome was at least a 2-level improvement in the Diabetic Retinopathy Severity Scale (DRSS) at 52 weeks.

Main Results:

• 80.1% of PDS Q36W participants achieved a ≥2-step DRSS improvement vs 9.0% in controls (P<.001).
• PDS Q36W significantly reduced the development of CI-DME, proliferative diabetic retinopathy (PDR), or anterior segment neovascularization (ASNV) (7.1% vs 47.0%).
• A transient decrease in best-corrected visual acuity (BCVA) was observed post-implantation, which resolved by 12 weeks.

Conclusions:

• The PDS Q36W demonstrated superior efficacy in improving DRSS scores and reducing complications in NPDR at 1 year.
• Safety outcomes were consistent with prior reports, though transient BCVA decrease requires consideration.
• The PDS offers a promising, less frequent treatment alternative for NPDR management.