Short-term Effect of Intravitreal Dexamethasone Implant in Refractory Diabetic Macular Edema

Asociación para Evitar la Ceguera en México

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: Intravitreal dexamethasone implant

Study type: Interventional

Funder types: Other

Identifiers

NCT05736081

RE-20-13

Details and patient eligibility

About

The goal of this clinical trial es to learn about the short term effects of intravitreal dexamethasone implant (IDI) in patients with refractory diabetic macular edema. The main question it aims to answer is:

How fast does the diminishing in central retinal thickness has statistical significance after IDI in patients with refractory diabetic macular edema? Patients will be evaluated by OCT before and after the implant.

Full description

Patients were evaluated at baseline, 2 hours, 3 hours, 24 hours, 1 week and 1 month post IDI

Enrollment: 15 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with type 1 or type 2 diabetes
• diabetic macular edema involving the foveal center with CRT >300 μm measured by OCT
• at least 3 and maximum 9 monthly intravitreal injections of anti-VEGF

Exclusion criteria

• uncontrolled diabetes (blood glucose ≥ 250 mg/dL at any time
• previous IDI
• any condition precluding adequate fundus visualization
• uncontrolled glaucoma
• papillary excavation ≥ 0.7

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Intravitreal dexamethasone implant

Experimental group

Description:

All patients were included here and received one intravitreal dexamethasone implant 0.7mg

Treatment:

Drug: Intravitreal dexamethasone implant