Chloroprocaine Gel for Retinal Conditions

(Quell Trial)

This trial tests whether a new eye gel, IHEEZO, matches the usual anesthesia in reducing pain during eye injections for retinal conditions like macular edema or diabetic retinopathy. Participants will receive either the IHEEZO gel with a sham subconjunctival injection or the routine anesthesia with real injections. The trial aims to determine if participants experience little to no pain during the procedure and to monitor any side effects. It seeks adults who need anti-VEGF eye injections and have previously received at least three of these injections. As a Phase 4 trial, this research involves an FDA-approved treatment, ensuring its proven effectiveness, and aims to understand its benefits for more patients.

You will need to stop using pain medications, opioids, analgesics, or NSAIDs (non-steroidal anti-inflammatory drugs) within 24 hours before your first visit. The trial does not specify other medication restrictions, so it's best to discuss your current medications with the study team.

Research has shown that chloroprocaine eye gel 3% is generally safe and well-tolerated. In past studies, patients using this gel for eye procedures like cataract surgery found it effective and experienced only minor side effects. These studies identified no major safety concerns with chloroprocaine gel in such situations. Additionally, a review of the gel found no specific safety issues related to its use.

Researchers are excited about the Chloroprocaine Gel for retinal conditions because it offers a novel approach to anesthesia during eye procedures. Unlike the standard routine anesthesia, which involves proparacaine drops followed by a lidocaine injection, Chloroprocaine Gel is administered as topical drops and is followed by a sham injection, eliminating the need for a real needle injection at this stage. This new method could enhance patient comfort by reducing the invasiveness of the anesthesia process. Additionally, it uses chloroprocaine, an active ingredient that might offer a different onset and duration of action compared to traditional anesthetics, potentially improving the overall procedure experience.

This trial will compare the effectiveness of chloroprocaine 3% eye gel with routine anesthesia methods. Studies have shown that chloroprocaine 3% eye gel effectively numbs the eye. Research found it works as well as other common anesthetics like proparacaine and lidocaine. In some reports, 80% of patients stated it was as good as or better than proparacaine. The gel's thinner consistency makes it easier to apply. It also has a strong safety record, indicating it is generally safe to use.¹²³⁴⁶