Ranibizumab PDS Implant for Diabetic Retinopathy

(PAVILION Trial)

This trial tests a new method for treating diabetic retinopathy, a common eye issue in people with diabetes that can lead to vision loss. The study compares two treatments: one group receives a Ranibizumab implant (PDS Implant Pre-Filled with 100 mg/mL Ranibizumab), while the other group receives regular eye injections of the same medicine (Intravitreal Ranibizumab 0.5 mg Injection). The researchers aim to determine if the implant can maintain vision stability as well as, or better than, the injections. Individuals with diabetes diagnosed with certain levels of diabetic retinopathy, without significant eye swelling, might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

Research has shown that the Port Delivery System (PDS) with ranibizumab is generally well-tolerated. In studies on diabetic eye conditions, patients receiving ranibizumab through PDS every 24 weeks reported positive experiences. The treatment proved effective, with most individuals not experiencing serious side effects. Some reported minor issues like eye irritation or redness, but these were uncommon.

For ranibizumab injections directly into the eye, past patients demonstrated that the treatment is safe and well-tolerated. These injections have been used for other eye conditions, with most individuals experiencing only mild and temporary side effects, such as slight discomfort or a feeling of pressure in the eye.

Unlike the standard of care for diabetic retinopathy, which usually involves regular intravitreal injections, the Ranibizumab PDS Implant offers a novel delivery method. This implant is surgically inserted and allows for a slow, sustained release of the medication, potentially reducing the frequency of treatments to every 36 weeks. Researchers are excited about this treatment because it could significantly ease the treatment burden for patients, offering a more convenient and less invasive option compared to frequent injections. This innovation might improve patient adherence and overall outcomes by ensuring consistent drug delivery over extended periods.

Research has shown that using a Port Delivery System (PDS) to deliver ranibizumab effectively treats eye conditions like diabetic macular edema (DME). In this trial, participants in the PDS arm will receive the PDS implant pre-filled with ranibizumab, providing a steady supply of the medication every 36 weeks. This approach matches the effectiveness of monthly injections in maintaining vision. Patients using the PDS experienced similar vision improvements to those receiving regular injections. The treatment is generally well-tolerated, with any temporary vision changes typically resolving within a few weeks after device implantation. Overall, the PDS with ranibizumab shows promise for managing diabetic retinopathy without frequent injections.²⁶⁷⁸⁹