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

NCT ID: NCT06846073

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-30
• Study Completion Date: 2026-12-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

The patients will receive the combination of intravitreal anti-VEGF and dexamethasone implants injections.

Group Type: EXPERIMENTAL

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

Intervention Type: COMBINATION_PRODUCT

Early combination of intravitreal dexamethasone implant and anti-VEGF injection for the treatment of DME.

Anti-VEGF injections monotherapy

The patients will receive intravitreal anti-VEGF injections.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo Eye Hospital

OTHER

Sponsor Role: collaborator

Jiaxing Hospital of T.C.M

UNKNOWN

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhiqing Chen, M.D.

Role: STUDY_CHAIR

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

Locations

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

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

2024-0369

Identifier Type: -

Identifier Source: org_study_id