Tarcocimab + Tabirafusp for Wet Age-Related Macular Degeneration

(DAYBREAK Trial)

This trial tests new treatments for wet age-related macular degeneration (wAMD), a condition that affects eyesight as people age. The study evaluates the effectiveness and safety of two new drugs, Tarcocimab Tedromer and Tabirafusp Tedromer, compared to Aflibercept, a current treatment. Suitable candidates for this trial are those who have never received treatment for their wAMD and experience changes in central vision due to abnormal blood vessel growth in the retina. As a Phase 3 trial, this study serves as the final step before FDA approval, offering participants a chance to contribute to the development of potentially groundbreaking treatments.

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 both tabirafusp tedromer and tarcocimab tedromer have promising safety results from earlier studies. Early trials found tabirafusp tedromer to be safe and effective in maintaining or improving vision over two years for people with wet age-related macular degeneration (AMD). Most patients did not need frequent doses, indicating good tolerance.

For tarcocimab tedromer, studies found no significant difference in cataract development between patients treated with tarcocimab and those receiving the standard treatment, aflibercept. This balance in side effects is a positive sign of safety.

Unlike the standard treatments for wet age-related macular degeneration, which typically involve regular injections like aflibercept, tabirafusp tedromer and tarcocimab tedromer stand out for their potential to reduce injection frequency. Both treatments use a unique approach by delivering them intravitreally with the possibility of extending the intervals between doses after initial monthly administrations. Researchers are excited about these therapies because they could offer patients a more convenient treatment schedule, potentially improving adherence and overall outcomes.

This trial will compare Tabirafusp Tedromer and Tarcocimab Tedromer as separate treatments for wet age-related macular degeneration (wAMD). Research has shown that both treatments are promising. Participants who received Tarcocimab Tedromer experienced better results, requiring fewer eye injections. For those receiving Tabirafusp Tedromer, new dosing schedules are under development to potentially extend the time between doses. These treatments are compared to Aflibercept, a common wAMD treatment, to evaluate their effectiveness and safety. Early results suggest these new treatments might perform as well as or better than current options, with less frequent dosing.¹²³⁶⁷