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

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ClinicalTrials.gov Identifier: NCT02639507
Recruitment Status : Recruiting
First Posted : December 24, 2015
Last Update Posted : January 1, 2016
Sponsor:
Information provided by (Responsible Party):
Michael W. Stewart, M.D., Mayo Clinic

Brief Summary:
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 Intervention/treatment
Diabetes With Diabetic Retinopathy With Macular Edema Procedure: Vitrectomy

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients - the ICV-DME Study
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. average (mean) improvement in Best Corrected Visual Acuity (BCVA) as measured with Snellen visual acuity [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639507


Contacts
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Contact: Michael W Stewart, MD 904-953-2232 stewart.michael@mayo.edu
Contact: Shannon L Kennedy, BA 904-953-7439 kennedy.shannon@mayo.edu

Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Michael W Stewart, MD    904-953-2232    stewart.michael@mayo.edu   
Contact: Shannon Kennedy    904-953-7839    kennedy.shannon@mayo.edu   
Mayo Clinic in Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Shannon Kennedy    904-953-7439    kennedy.shannon@mayo.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Michael W Stewart, MD Mayo Clinic

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Responsible Party: Michael W. Stewart, M.D., PI, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02639507     History of Changes
Other Study ID Numbers: 14-008884
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: January 1, 2016
Last Verified: December 2015

Additional relevant MeSH terms:
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Edema
Macular Edema
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases