International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients (ICV-DME)
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The purpose of this research is to evaluate the effectiveness of vitrectomy for the treatment of diabetic macular edema. Diabetes is known to cause retinal blood vessels to leak, leading to swelling of the central retina (macula), and decreased vision. Removing the vitreous gel with vitrectomy surgery is known to decrease the swelling caused by diabetes. Diabetic retinopathy is often treated with laser or injections of medicine in to the eye.
Condition or disease
Diabetes With Diabetic Retinopathy With Macular Edema
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.
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)
Likelihood of needing intraocular surgery within 6 months
Hard exudates involving the fovea
Proliferative diabetic retinopathy with any evidence of retinal traction