NCT06846073

Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of DME.

A Prospective Clinical Study on the Early Combined Use of Dexamethasone Intravitreal Implant and Anti-VEGF in the Treatment of Diabetic Macular Edema (DME) in Naive Patients.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the efficacy of dexamethasone implant combined with anti-VEGF superior to anti-VEGF monotherapy in the treatment of DME in Chinese patients. The main questions it aims to answer are: 1. Whether combination therapy improves the best corrected visual acuity at 6 months and 12 months? 2. Does combination therapy improve retinal anatomy better than monotherapy at each time point? Researchers will compare the combination therapy to the monotherapy to see if dexamethasone implant combined with anti-VEGF will leads to better results. Participants will: 1. be randomly assigned to one of two groups with equal probability to receive the combination of intravitreal anti-VEGF and dexamethasone implant injections or intravitreal anti-VEGF injections. 2. During the first 3 months, patients in both groups will receive monthly injections of anti-VEGF. In the double protocol group, the first dexamethasone implant injection will be administered simultaneously with the first loading dose of anti-VEGF injections. Between 4 and 12 months, patients will receive intravitreal anti-VEGF injections as needed/pro-re-nata (PRN). 3. Patients will have regular follow-up. Routine examination includes Central retinal thickness (CRT), intraocular pressure (IOP), slit lamp examination, best corrected visual acuity (BCVA) and OCT.

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	The combination of intravitreal anti-VEGF and dexamethasone implants injections.	Early combination of intravitreal dexamethasone implant and anti-VEGF injection for the treatment of DME.

Timeline

• Start date: 2024-07-30
• Primary completion: 2026-07-31
• Completion: 2026-12-31
• First posted: 2025-02-25
• Last updated: 2025-02-25

Locations

1 site across 1 country: China