International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-06-30

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes With Diabetic Retinopathy With Macular Edema

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No