High Dose Eylea for Diabetic Retinopathy

(HERO Trial)

This trial aims to test the safety of a high dose of aflibercept (marketed as Eylea), a medication for treating proliferative diabetic retinopathy, a serious eye condition related to diabetes. The trial will explore whether this dose can help manage the condition without causing macular edema (swelling in the center of the retina). Participants will receive the medication at specific intervals and may also receive other treatments based on their response. Ideal candidates are those with type 1 or type 2 diabetes who have been diagnosed with proliferative diabetic retinopathy. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

The trial requires a 3-month period without any anti-VEGF treatments in the study eye before joining. Other medications are not specifically mentioned, so it's best to discuss your current medications with the trial team.

Research has shown that aflibercept, particularly in higher doses, is generally well-tolerated by patients with diabetic eye conditions. Studies have identified common side effects, such as bleeding on the eye's surface, eye pain, and cataracts, occurring in 5% or more of patients. Notably, a study on high-dose aflibercept found that it continues to improve vision over three years without new safety concerns.

Unlike the standard of care for diabetic retinopathy, which typically includes treatments like regular doses of aflibercept or ranibizumab, the high-dose aflibercept being studied is unique due to its extended dosing intervals. Researchers are excited about this treatment because it offers a potential for patients to receive injections less frequently, which can significantly improve convenience and adherence. Additionally, this high-dose approach may enhance the effectiveness in controlling disease activity over a longer period, potentially leading to better visual outcomes for patients. The ability to adjust treatment intervals based on individual response also allows for a personalized approach that could further optimize patient care.

Research has shown that aflibercept effectively treats diabetic retinopathy. Studies have found that many patients experienced significant improvement in their condition over two years. In this trial, participants will receive a higher dose of aflibercept (8 mg). Previous research indicates that this dosage can continue to provide visual and health benefits with fewer injections over three years. Other studies have shown that aflibercept significantly reduces retinal thickness, a positive sign of its effectiveness. These findings suggest that aflibercept can help improve vision and manage diabetic retinopathy effectively.¹⁵⁶⁷⁸