Study of Levosulpiride to Improve Retinal Changes in Adults Aged 40 to 69 With Diabetic Retinopathy and Diabetic Macular Edema

What this Trial Is About

Researchers are evaluating the safety and effectiveness of levosulpiride in improving eye problems caused by diabetic macular edema DME and diabetic retinopathy DR. These conditions are leading causes of vision loss in adults with diabetes, and current treatments like laser therapy or anti-angiogenic drugs have limitations and risks. This study explores a new approach by raising prolactin hormone levels using levosulpiride, aiming to protect the retina and reduce disease progression. Participants with different stages of diabetic eye disease will be randomly assigned to receive either levosulpiride or a placebo pill taken orally three times a day. Some groups include patients undergoing vitrectomy surgery or receiving standard anti-angiogenic treatment with ranibizumab levosulpiride or placebo is given alongside these therapies. Treatment durations vary from one week to 24 weeks depending on the group, always combined with regular diabetes and blood pressure management. During the study, participants will undergo detailed eye exams including imaging tests like optical coherence tomography and fundus photography, blood tests to measure prolactin and other markers, and vision assessments. Researchers will monitor retinal changes, visual acuity, and hormone levels to assess treatment effects. Safety and adherence will be carefully tracked throughout the study period, which extends up to several months. The trial also involves thorough data collection and quality control to ensure reliable results.

Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema