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

NCT06498050 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-06-04

No results posted yet for this study

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

Conditions

Interventions

DRUG

intravitreal injection of Brolucizumab 6 mg in study eye

After disinfecting the conjunctival sac and administering a topical anesthetic, an intravitreal injection of Brolucizumab at a dose of 6 mg is given.

Sponsors & Collaborators

  • Beijing Novartis Pharma

    collaborator INDUSTRY

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Honghua Yu · Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2025-07-10
Completion
2025-07-10

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06498050 on ClinicalTrials.gov