Randomized Double-Blind Study Comparing Ranibizumab 10mg/ml Injection and Lucentis for Diabetic Macular Edema Intravitreal Injection Treatment Evaluating Vision and Safety

What this Trial Is About

Diabetic macular edema (DME) is a complication of diabetic retinopathy that causes retinal thickening near the center of the macula, leading to vision loss. This condition results from damage to the blood-retinal barrier due to diabetes, causing leakage and swelling in the retina. The study focuses on evaluating the efficacy and safety of ranibizumab, a monoclonal antibody targeting vascular endothelial growth factor (VEGF), which plays a key role in increasing retinal vascular permeability and edema. This randomized, double-blind, parallel study will include 70 patients with DME. Participants will receive three doses of 0.5 mg intravitreal injections of either the test product (Ranibizumab 10mg/ml Injection by Incepta) or the reference product (Lucentis) every four weeks, on Day 0, Week 4, and Week 8. After the first injection, a safety visit will be conducted 48 hours later, with additional safety follow-ups before each injection and 48 hours after the second and third injections. The final visit will occur at Week 12 for efficacy and safety evaluation. During the study, participants will undergo assessments including best corrected visual acuity (BCVA) and central subfield thickness (CST) measurements at baseline and Week 12. Safety will be closely monitored throughout the study with regular visits and ocular examinations. The total participation duration is approximately 12 weeks, during which researchers will evaluate changes in vision and retinal swelling to compare the two ranibizumab treatments.

A Efficacy and Safety Study of Ranibizumab 10mg/ml Injection (Incepta) in Patients With Diabetic Macular Edema