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OpenTrials
Completed

NCT Number: NCT02639507

International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

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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Key information

Conditions

Diabetes With Diabetic Retinopathy With Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitrectomy

Procedure

Primary outcomes

  1. average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study

Acronym: ICV-DME

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2015
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.