International Consortium Investigating Early Vitrectomy in Diabetic Macular Edema Patients

NCT02639507 | Completed DMC

• 1 other identifier: 14-008884
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes With Diabetic Retinopathy With Macular Edema

Outcome Measures

Primary Outcomes (1)

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

  6 months

Interventions

Vitrectomy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Michael W Stewart, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 24, 2015
• Study Start: June 1, 2015
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Locations

US (2)