International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients (ICV-DME)
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ClinicalTrials.gov Identifier: NCT02639507 |
Recruitment Status :
Completed
First Posted : December 24, 2015
Last Update Posted : March 26, 2020
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Condition or disease | Intervention/treatment |
---|---|
Diabetes With Diabetic Retinopathy With Macular Edema | Procedure: Vitrectomy |
Study Type : | Observational |
Actual Enrollment : | 40 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 |
Actual Primary Completion Date : | March 2020 |
Actual Study Completion Date : | March 2020 |

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

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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 |
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
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.

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
United States, Florida | |
Mayo Clinic Florida | |
Jacksonville, Florida, United States, 32224 | |
Mayo Clinic in Florida | |
Jacksonville, Florida, United States, 32224 |
Principal Investigator: | Michael W Stewart, MD | Mayo Clinic |
Responsible Party: | Michael W. Stewart, M.D., PI, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT02639507 |
Other Study ID Numbers: |
14-008884 |
First Posted: | December 24, 2015 Key Record Dates |
Last Update Posted: | March 26, 2020 |
Last Verified: | March 2020 |
Macular Edema Diabetic Retinopathy Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases |
Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |