International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients (ICV-DME)

Eligible patients will have the following characteristics:

• Background diabetic retinopathy.
• Center involving macular edema with CST > 325 µm as measured by SD-OCT.
• Predominantly intact (80%) ELM and IS/OS lines within 500 µm of the fovea on both horizontal and vertical SD-OCT scans.
• Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive

Inclusion Criteria:

• Men and women, > 18 years of age with type 1 or 2 diabetes mellitus diagnosed and treated by an endocrinologist, internist or family medicine physician
• Background diabetic retinopathy
• DME with central subfield thickness (CST) > 325 µm by Spectral Domain Optical Coherence Tomography (SD-OCT)
• HbA1c level of < 10.0 mg/dl
• Previous cataract surgery with implantation of a stable posterior chamber intraocular lens or a phakic eye with 1+ (out of 4+ scale) or less lens opacification
• Predominantly intact (80%) external limiting membrane (ELM) and photoreceptor inner/outer segment (IS/OS) lines within 500 µm of the fovea on horizontal and vertical SD-OCT scans
• Best corrected Snellen visual acuity from 20/40 to 20/280 inclusive.

Exclusion Criteria:

• Intraocular anti-vascular endothelial growth factor (VEGF) injection within the previous 3 months
• Systemic anti-VEGF or receptor tyrosine kinase inhibitor therapy within the previous 3 months
• Intraocular corticosteroid injection within the previous 6 months
• Peri-ocular corticosteroid injection within the previous 3 months
• Vitreomacular traction on SD-OCT scan (epiretinal membrane is allowed)
• Previous anterior or pars plana vitrectomy
• Glaucoma (IOP of > 21 mmHg or regular use of more than 2 IOP lowering drugs)
• Previous trabeculectomy
• Likelihood of needing intraocular surgery within 6 months
• Hard exudates involving the fovea
• Proliferative diabetic retinopathy with any evidence of retinal traction
• Cataract of grade 2+ or greater.