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Clinical Trials in China / NCT06846073
Active, not recruiting Not applicable

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

NCT06846073 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2024-07-30
Last updated
2025-02-25

Condition(s) studied

Diabetic Macular Edema (DME)

Investigational drug(s) / intervention(s)

The combination of intravitreal anti-VEGF and dexamethasone implants injections.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Type 1/type 2 diabetes mellitus with good glycaemic control and glycated haemoglobin ≤ 10.0%; DR stage II-III; * DME with involvement of the central concavity and resulting in the patient's vision loss; * Central retinal thickness (CRT) ≥250 μm; * No refractive interval clouding and pupillary constriction affecting fundus examination; * No Pan-Retinal Photocoagulation treatment within 3 months before enrolment; * No macular laser treatment in the past or during the follow-up period; * Good patient cooperation and compliance. Exclusion Criteria: * other macular lesions such as macular preexisting membranes, macular schisis, or other causes of macular oedema such as uveitis and central retinal vein occlusion; * Co-existence of diabetic optic neuropathy; * Previous intraocular injection therapy such as anti-VEGF drugs or glucocorticoid drugs in the target eye; * History of vitreoretinal surgery in the target eye; * A history of uncontrolled stable glaucoma or hypertension, hormonal hypertension in the target eye; * Aphakic eyes with posterior lens capsule rupture with an anterior chamber IOL (ACIOL), iris or transscleral fixed intraocular IOLs, and patients with posterior lens capsule rupture; * Pregnant or breastfeeding patients, uncontrolled hypertension within 3 months, cerebrovascular accident or myocardial infarction, uncontrolled diabetes mellitus, or other reasons for not being able to co-operate with the relevant examination; * Lost visits and data loss.

Primary outcome measure(s)

  • Average change in best corrected visual acuity (BCVA) of each group from baseline to the end of month 6. — 6 month.
    BCVA was measured using the log Mar visual acuity chart or the ETDRS visual acuity chart.

Trial sites (1)

FacilityCityRegionStatus
Eye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

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Other trials for the same condition

Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema Recruiting
Zhuochuming®-3T&E-DME Study (Treatment-naïve Patients) Starting soon
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME). Recruiting
Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients Recruiting
A Phase I Study of GenSci148 Intravitreal Injection for Neovascular Age-related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06846073 on ClinicalTrials.gov ↗ ← All trials in China