Brolucizumab Efficacy and Safety Single-Arm Descriptive Trial in Patients With Persistent Diabetic Macular Edema

The goal of this clinical trial is to evaluate the efficacy of brolucizumab 6 mg in Chinese patients with persistent diabetic macular edema (DME). It will also learn about the safety of brolucizumab 6 mg. The main questions it aims to answer are: Does brolucizumab 6 mg reduce central subfield thickness (CST) and improve best-corrected visual acuity (BCVA) of participants? What medical problems do participants have after receiving intravitreal injections of brolucizumab 6 mg? Researchers will compare baseline CST and BCVA to those at each post-baseline visit to see if brolucizumab 6 mg works to treat persistent DME. Participants will: Receive brolucizumab 6 mg via intravitreal injections following two treatment patterns: Treatment Pattern 1: every 6 weeks for 5 injections Treatment Pattern 2: every 6 weeks for 3 injections followed by 1 injection after 12 weeks Visit the clinic 8 times for treatment and assessments over the course of 28 weeks

NCT Number	NCT06498050
Lead Sponsor	Guangdong Provincial People's Hospital Collaborators: Beijing Novartis Pharma
Conditions	Diabetic Macular Edema
Enrollment	52 participants
Start Date	2024-07-10
Primary Completion	2025-07-10 (estimated)
Study Completion	2025-07-10 (estimated)
Updated on ClinicalTrials.gov	2025-06-04