Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-24 @ 5:09 PM
NCT ID:
NCT06498050
Brief Summary:
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
Detailed Description:
This study is a single-arm, open-label study designed to evaluate the efficacy and safety of intravitreal injections (IVI) of brolucizumab 6 mg in Chinese subjects with persistent diabetic macular edema (DME). The study consists of a 2-week screening phase, followed by a 28-week period from the point of informed consent.
Intervention, assessments and analyses will be performed in Guangdong Provincial People's Hospital. Data from assessments will be extracted from the patients' medical records at the following time points: baseline, Week 1, Week 6, Week 12, Week 16, Week 18, Week 24, and at Week 28.
Safety data will be collected from any time point thoughout the study. Any adverse events identified will be recorded and treated per recommended standard treatment guideline combined with local clinical practice.
Study:
NCT06498050
Study Brief:
Protocol Section:
NCT06498050