Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Clinically Significant Macular Edema; Diabetic Macular Edema; Diabetic Retinopathy

Treatments: Drug: Aflibercept Injection [Eylea]

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03453281

17-07-0750

Details and patient eligibility

About

This is a one month pre post intervention study. Subjects with diabetic macular edema were given intravitreal anti VEGF (Aflibercept) injection. Central retinal thickness, macular electrophysiology, and visual acuity were observed one week and one month after injection was given to the eye to describe early anatomical, physiological, and clinical changes. We hypothesized that changes to these outcomes can be found and documented.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Minimum age of 18 y.o.
• Diagnosed with Type 1 or 2 Diabetes Mellitus
• Have either one of mild non-proliferative diabetic retinopathy (NPDR), moderate NPDR, severe NPDR, or Proliferative Diabetic Retinopathy with clinically significant macular edema according to Early Treatment for Diabetic Retinopathy Study (ETDRS) criteria
• Best corrected visual acuity between one meter finger counting to 6/12 (ETDRS chart)
• Minimum Central Macular Thickness by Optical Coherence Tomography examination of 250 um
• Willing to participate and sign the informed consent.

Exclusion criteria

• Ongoing pregnancy or planning to be pregnant for the next 6 months.
• Media opacity (e.g. corneal scar, corneal edema, cataract, vitreous hemorrhage) which make macular OCT not possible
• History of intraocular surgery in the last 6 months
• Vitreoretinal surface disorders e.g. epiretinal membrane, vitreoretinal traction
• History of panretinal laser photocoagulation in the last 6 months
• Presence of iris neovascularization
• History of eye trauma
• HbA1c level > 10,0 %
• Any other contraindication(s) for intravitreal anti VEGF injection.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 1 patient group

Aflibercept Injection [Eylea]

Experimental group

Description:

Intravitreal injection of 2 mg in 0.05 ml Aflibercept. Frequency: once Duration: 10-15 minutes

Treatment:

Drug: Aflibercept Injection [Eylea]