High Dose Aflibercept Treatment for Diabetic Macular Edema in Adults With Previous Vitrectomy Surgery

What this Trial Is About

Researchers are investigating the use of high dose aflibercept in patients with diabetic macular edema DME who have previously undergone vitrectomy surgery. This study focuses on how the pharmacokinetics of anti-VEGF therapy differ in eyes that have had vitrectomy, as protein clearance is faster in these eyes, potentially making standard treatments less effective. The study evaluates a treat-extend-stop TES protocol adapted for DME patients, aiming to improve visual acuity and reduce central macular thickness CMT. The treatment involves intravitreal injections of 8 mg aflibercept, administered following the TES protocol. Patients receive three initial loading doses at 4-to-6-week intervals. Based on clinical examination and imaging, the interval between doses is extended by 1 to 2 weeks if the macula is dry, or reduced if fluid or vision worsening occurs. This adjustment continues up to 12 weeks between visits while maintaining a fluid-free macula. The study lasts for one year, during which patients receive active treatment with high-dose aflibercept. Participants attend regular visits where visual acuity and CMT are measured before and during treatment. Diabetic retinopathy is assessed using wide-field fundus photos and fluorescein angiography at baseline, six months, and one year. Safety is closely monitored throughout the study, including reporting of serious adverse events and special eye-related conditions. Researchers will analyze changes in visual acuity, CMT, and treatment intervals to evaluate treatment impact over 12 months.

High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy