International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

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.