Axitinib Implant for Age-Related Macular Degeneration

This trial tests a new implant called OTX-TKI (also known as the Axitinib Implant) for individuals with neovascular age-related macular degeneration (nAMD). The researchers aim to determine if this implant can improve or stabilize vision more effectively than standard treatments, such as aflibercept injections. Participants may receive different treatments, including the OTX-TKI implant or varying doses of aflibercept. Ideal candidates have recently been diagnosed with nAMD and may have already tried aflibercept injections. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

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

Studies have shown that the OTX-TKI implant, which contains the drug Axitinib, is generally well-tolerated. Previous research reported no unexpected safety issues, indicating that users did not encounter new or surprising problems. The evidence suggests that most patients handle the treatment well, which bodes well for its safety in humans.¹²³⁴⁵

Researchers are excited about OTX-TKI for age-related macular degeneration because it offers a novel delivery method as an implant, which could potentially reduce the frequency of treatments compared to standard care injections like Aflibercept. This implant slowly releases Axitinib, a tyrosine kinase inhibitor, directly into the eye, which might enhance the treatment's effectiveness and duration. Unlike other treatments that require regular injections, this innovative approach aims to provide sustained efficacy, improving convenience and adherence for patients.

Research shows that OTX-TKI, a small implant containing the drug axitinib, holds promise for treating neovascular age-related macular degeneration (AMD). Earlier studies demonstrated a reduction in the need for additional treatments by 89%. In this trial, participants may receive the OTX-TKI implant, which releases the medication slowly over up to nine months, potentially reducing the number of injections needed each year. Specifically, patients maintained disease control and stable vision with just one or two injections annually. These early results suggest that OTX-TKI might effectively manage wet AMD.¹⁵⁶⁷⁸