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

March 24, 2020 updated by: Michael W. Stewart, M.D., Mayo Clinic

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Michael W Stewart, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

December 22, 2015

First Posted (Estimate)

December 24, 2015

Study Record Updates

Last Update Posted (Actual)

March 26, 2020

Last Update Submitted That Met QC Criteria

March 24, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-008884

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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