Intravitreal KSI-101 for Swelling of the Retina

(PINNACLE Trial)

This trial tests a new treatment called KSI-101, an injection for individuals with macular edema, which causes swelling in the part of the eye responsible for clear vision. Researchers aim to determine the effectiveness and safety of KSI-101 for this condition. Participants will receive either the KSI-101 injection or a sham (inactive) injection every four weeks. Suitable candidates have swelling due to eye inflammation not caused by diabetes or other specific eye issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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

Research has shown that KSI-101 was well tolerated in earlier studies. Patients who received KSI-101 generally did not encounter major safety issues. In a follow-up study, KSI-101 continued to perform well, with most patients not experiencing serious side effects. This suggests that KSI-101 may be safe for humans. However, as with any treatment, participants should discuss possible risks with their healthcare provider.¹²³⁴⁵

Unlike the standard treatments for retinal swelling, which often involve repeated injections of anti-VEGF agents like ranibizumab or aflibercept, KSI-101 offers a unique approach. KSI-101 is a novel intravitreal injection designed to deliver its medication directly into the eye, potentially reducing the frequency of treatments required over time. Researchers are particularly excited about KSI-101 because it combines two different molecular approaches into one treatment, potentially enhancing its effectiveness and duration of action compared to existing options. This could mean fewer office visits and a more convenient treatment schedule for patients suffering from retinal swelling.

Research has shown that KSI-101 holds promise for treating macular edema, which is swelling in the eye due to inflammation. In earlier studies, over 90% of patients experienced a reduction in this swelling. In this trial, participants will receive either the 5 mg or 10 mg dose of KSI-101, both of which have cleared fluid buildup in the eye, a key sign of swelling. This suggests that KSI-101 could greatly improve vision by reducing eye swelling and could be an effective option for managing macular edema.¹²³⁶⁷